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Medical Devices

July 2014 PMA Approvals

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P090029
7/24/14
PRESTIGE® LP Cervical Disc Medtronic Sofamor Danek USA, Incorporated
Memphis, TN 38132
Approval for the PRESTIGE® LP Cervical Disc. This device is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level abnormality localized to the level of the disc space and at least one of the following conditions confirmed by imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The PRESTIGE® LP Cervical Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of non-operative treatment or have had the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management prior to implantation of the PRESTIGE® LP Cervical Disc.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N16837/S015
7/14/14
Special
Artegraft Collagen Vascular Graft Artegraft, Inc.
North Brunswick, NJ
08902
Approval for a labeling change to modify the sizing convention from outer diameter to inner diameter of the graft.
P870024/S049
7/28/14
180-Day
Paragon CRT®, Paragon CRT® 100, Paragon RG-4TM Rigid Gas Permeable Contact
Lens for Overnight Corneal Refractive Therapy
Paragon Vision Sciences, Inc.
Mesa, AZ
85204
Approval for a labeling update to the Package Insert and Patient Information Booklet to include the results from a Section 522 Postmarket Surveillance Study (PAS).
P890003/S297
7/9/14
180-Day
CareLink Encore Programmer, CareLink 2090 Programmer,
CareLink Home Monitor, CareLink Express Monitor,
CardioSight Reader,
Device Data Management Application (DDMA)
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Medtronic Viva CRT-P Model C6TR01 Implantable Pacemaker with Cardiac Resynchronization; Programmer Software Application Model 9995 v8.3; and updates to the Medtronic CareLink Monitor Model 2490G, CardioSight Reader Model 2020A and CareLink Express Model 2020B firmware, and to the Model 2491 Device Data Management Application (DDMA).
P890003/S309
7/3/14
180-Day
CareLink Monitor, CardioSight Reader, CareLink Express, Device Data
Management Application (DDMA)
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Viva/Brava Quadripolar Cardiac Resynchronization Therapy Defibrillator   (CRT-D) devices and is indicated for patients who require ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life- threatening ventricular arrhythmias, for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias and for providing cardiac resynchronization therapy in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the classifications provided in the labeling.
P890055/S048
7/15/14
Special
MedStream Programmable Infusion System Codman & Shurtleff, Inc.
Raynham, MA 02767
Approval for an additional inspection step in the manufacturing process of the MedStream device to require a post-sterilization Fill Level Sensor (FLS) functional inspection.
P890055/S056
7/30/14
Real-Time
MedStream Programmable Infusion Pump Codman & Shurtleff, Inc.
Raynham, MA 02767
Approval to replace electrical gap welding or laser welding of the MedStream pump’s electrical components on the Printed Circuit Board (PCB) with a thermobrazing process, modify the extremity of the Flex FLS, Flex RF, and Battery Ribbon component to include apertures, and eliminate the current in-process micro pull test for each connection.
P890055/S057
7/11/14
180-Day
Codman 3000 Constant-Flow Infusion Pump and MedStream Programmable Infusion Codman & Shurtleff, Inc.
Raynham, MA 02767
Approval for a manufacturing site located at Sterigenics Belgium (Petit-Rechain) S.A. in Verviers, Belgium.
P910023/S336
7/24/14
Real-Time
LATITUDE NXT Patient Management System, LATITUDE NXT Release 3.0 St. Jude Medical
Sunnyvale, CA 94085
Approval for cybersecurity updates to the Merlin@Home transmitters.
P910077/S143
7/16/14
Real-Time
LATITUDE NXT Patient Management System Boston Scientific Corporation
St. Paul, MN
55112
Approval for the Wave Communicator Model 6280 sw version v1.52.00; Wave Communicator Model 6290 sw version v2.02.00; Wave Communicator Model 6498 sw version v1.52.00; LATITUDE NXT System Software Model 6460 v.3.00.01; and Communicator Accessory and Literature Kit Model 6250.
P950005/S050
7/2/14
135-Day
Celsius, Celsius RMT, EZ Steer Non-Temp Sensing Ablation Catheters Biosense Webster, Inc.
Diamond Bar, CA 91765
Approval for applying a change in sterilization release method to the new line of catheters at the Santa Teresa, New Mexico facility.
P950015/S012
7/23/14
180-Day
Heart Laser CO2 TMR System Novadaq Tehnologies, Inc.
Richmond, British Columbia
Canada
V6V 2A2
Approval for a manufacturing site located at Ethox, in Buffalo, New York.
P950037/S135
7/16/14
Real-Time
REOCOR S/D External Pacermaker Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the replacement of the storage capacitor for the devices.
P960040/S316
7/16/14
Real-Time
TELIGEN, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN, and ORIGEN Family of ICDs Boston Scientific Corporation
St. Paul, MN
55112
Approval for Model 2868 Application Software version 3.04 and Firmware version A_v1.04 with Patch v4.01 and Firmware version B_v1.02 with Patch v3.01 for the devices.
P960058/S108
7/29/14
180-Day
HiResolution Bionic Ear System: Concave Universal Head Piece Advanced Bionics
Valencia, CA
91355
Approval for the Concave Universal Head Piece, a redesigned version of the current Universal Head Piece. The Concave Universal Head Piece supports both behind the ear and body worn Sound Processors and is intended for increase of wearing comfort for the HiRes90K Advantage implant users.
P970003/S169
7/2/14
Real-Time
DemiPulse Implantable Pulse Generator; Aspire HC Implantable Pulse Generator Cyberonics, Inc.
Houston, TX
77058
Approval for a change to the Printed Circuit Board Assembly manufacturing design requirement for voltage measurement accuracy and tolerance associated with its electrical testing.
P970004/S178
7/25/14
Special
InterStim Therapy for Urinary Control Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for changes to the labeling to add a warning regarding the risk of increased or uncontrolled bleeding and the use of anticoagulants prior to surgery for InterStim Therapy.
P980006/S022
7/11/14
180-Day
Bausch & Lomb PureVision2 (balafilcon A) Visibility Tinted Contact Lenses, Bausch &
Lomb PureVision2 Multi-Focal (balafilcon A) Visibility Tinted Contact Lenses, Bausch
& Lomb PureVision2 Toric (balafilcon A) Visibility Tinted Contact Lenses
Equate Monthly Single Vision (balafilcon A) Contact Lens, Equate Monthly Multi-Focal
(balafilcon A) Contact Lens, Equate Monthly Toric (balafilcon A) Contact Lenses, and
C-Vue ADDvantage Multifocal (balafilcon A) Visibility Tinted Contact Lenses
Bausch & Lomb, Inc.
Rochester, NY 14609
Approval for the addition of the following private label trade names: Equate Monthly Single Vision (balafilcon A) Contact Lens, Equate Monthly Multi-Focal (balafilcon A) Contact Lens, Equate Monthly Toric (balafilcon A) Contact Lenses, and C-Vue ADDvantage Multifocal (balafilcon A) Visibility Tinted Contact Lenses. The device, as modified, will be marketed under the trade name the Equate Monthly Single Vision (balafilcon A) Contact Lens and is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional.  The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +8.00D to -20.00D when prescribed for up to 30 days of extended wear and from +20.00D to -20.00D for daily wear or extended wear up to 7 days. The Equate Monthly Single Vision (balafilcon A) Contact Lens is also indicated for therapeutic use. Use as a bandage contact lens for corneal protection and corneal pain relief during treatment of ocular pathologies as well as post-surgical conditions. Applications of the Equate Monthly.   Single Vision (balafilcon A) Contact Lenses include but are not limited to conditions such as the following: 1) For corneal protection in conditions such as entropion, trichiasis, tarsal scars, recurrent corneal erosion and post surgical ptosis for corneal protection; 2) For corneal pain relief in conditions such as bullous keratopathy, epithelial erosion and abrasion, filamentary keratitis, post-keratoplasty; 3) For use as a bandage during the healing process of conditions such as chronic epithelial defects, corneal ulcer, neurotrophic keratitis, neuroparalytic keratitis, chemical bums, and post surgical epithelial defects; and, 4) For post-surgical conditions that include bandage use such as LASIK, PRK, PK, PTK, lamellar grafts, corneal flaps, and additional corneal surgical conditions. Equate Monthly Single Vision (balafilcon A) Contact Lenses for therapeutic use can also provide optical correction during healing if required. The device, as modified, will be marketed under the trade name The Equate Monthly Multi-Focal (balafilcon A) Contact Lens is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional.  The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with nondiseased eyes, exhibiting astigmatism of up to 2.00 diopters or less, that does not interfere with visual acuity.  The lens may be prescribed for Frequent/ Planned Replacement Wear or Disposable Wear in spherical powers ranging from +6.00D to -18.00D when prescribed for up to 30 days of Extended wear and from +20.00D to -20.00D for daily wear or extended wear up to 7 days with add powers ranging from +0.75D to +5.00D.  The device, as modified, will be marketed under the trade name the Equate Monthly Toric (balafilcon A) For Astigmatism and is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional.  The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +6.00D to -9.00D when prescribed for up to 30 days of extended wear and from +20.00D to -20.00D for daily wear or extended wear up to 7 days. The device, as modified, will be marketed under the trade name the C-Vue ADDvantage Multifocal (balafilcon A) Visibility Tinted Contact Lenses and are indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional.  The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or notaphakic persons with non-diseased eyes, exhibiting astigmatism of up to 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +6.00D to - 18.00D when prescribed for up to 30 days of extended wear and from +20.00D to - 20.00D for daily wear or extended wear up to 7 days with add powers ranging from +0.75D to +5.00D.
P980016/S452
7/9/14
180-Day
Maximo II DR, Maximo II VR,
Virtuoso II DR, Virtuoso II VR,
Secura DR, Secura VR Implantable Cardioverter Defibrillators
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Medtronic Viva CRT-P Model C6TR01 Implantable Pacemaker with Cardiac Resynchronization; Programmer Software Application Model 9995 v8.3; and updates to the Medtronic CareLink Monitor Model 2490G, CardioSight Reader Model 2020A and CareLink Express Model 2020B firmware, and to the Model 2491 Device Data Management Application (DDMA).
P980022/S154
7/10/14
Real-Time
Paradigm REAL-Time Revel System Medtronic Minimed
Northridge, CA 91325
Approval to lower the purity specification limit for the Chromium layer on Enlite™ Glucose Sensor (MMT-7008) of the MiniMed 530G System and Sof™ Glucose Sensor (MMT-7002, MMT-7003) of the Paradigm REAL-Time Revel System.
P980023/S057
7/3/14
180-Day
PROTEGO Family of ICD Leads Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the DF4 variants of the currently approved Ilesto/Iforia ICDs/CRT-Ds and LinoxSmart ICD leads.
P980025/S002
7/22/14
180-Day
Logicon Caries Detector GA Industries
Rancho Palos Verdes, CA
90275
Approval for the addition of software module PreScan to Logicon Caries Detector.  The device, as modified, will be marketed under the trade name Logicon Caries Detector and has revised indications for use: “The Logicon Caries Detector is a software device that is an aid in the diagnosis of caries that have penetrated into the dentin, on un-restored proximal surfaces of secondary dentition through the statistical analysis of digital intra-oral radiographic imagery. The device provides additional information for the clinician to use in his/her diagnosis of a tooth surface suspected of being carious. It is designed to work in conjunction with an existing Carestream Dental RVG digital x-ray radiographic system with Dental Imaging Software (DIS) for WINDOWS XP or higher.”
P980035/S358
7/9/14
180-Day
Advisa DR, Advisa DR MRI IPG Medtronic, Inc.
Mounds View, MN 55112
Approval for the Medtronic Viva CRT-P Model C6TR01 Implantable Pacemaker with Cardiac Resynchronization; Programmer Software Application Model 9995 v8.3; and updates to the Medtronic CareLink Monitor Model 2490G, CardioSight Reader Model 2020A and CareLink Express Model 2020B firmware, and to the Model 2491 Device Data Management Application (DDMA).
P980040/S048
7/24/14
180-Day
TECNIS OptiBlue 1-Piece intraocular lens Abbott Medical Optics Inc.
Santa Ana, CA 92705
Approval for a manufacturing site located at AMO Puerto Rico Manufacturing, Inc., in Anasco, Puerto Rico.
P990004/S024
7/2/14
180-Day
SURGIFOAM Absorbable Gelatin Sponge, USP Ethicon, Inc.
Somerville, NJ 08876
Approval for a manufacturing (packaging) site located at Ferrosan Medical Devices, Koksowa, Poland.
P990071/S027
7/2/14
180-Day
SmartAblate System Biosense Webster, Inc.
Diamond Bar, CA 91765
Approval for hardware modifications to the SmartAblate Irrigation Pump that update the hardware from version 1 to version 2.
P000058/S037
7/24/14
180-Day
INFUSE® Bone Graft and INFUSE® Bone GraftLT-Cage Lumbar Tapered Fusion Device Medtronic Spinal
Memphis, TN
38132
Approval for a manufacturing site located at Wyeth Farma, S.A, in De Los Reyes, Spain.
P010012/S355
7/16/14
Real-Time
COGNIS, INECEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN, and ORIGEN family of CRT-Ds and  Application Software Boston Scientific Corporation
St. Paul, MN
55112
Approval for Model 2868 Application Software version 3.04 and Firmware version A_v1.04 with Patch v4.01 and Firmware version B_v1.02 with Patch v3.01 for the devices.
P010014/S048
7/7/14
Special
Oxford® Partial Knee System Biomet U.K. Ltd.
Swindon, UK
SN3 5HY
Approval to update three contraindications in the Instructions for Use for the Oxford® Partial Knee System.
P010015/S227
7/9/14
180-Day
Viva CRT-P, Consulta CRT-P,
Syncra CRT-P
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Medtronic Viva CRT-P Model C6TR01 Implantable Pacemaker with Cardiac Resynchronization; Programmer Software Application Model 9995 v8.3; and updates to the Medtronic CareLink Monitor Model 2490G, CardioSight Reader Model 2020A and CareLink Express Model 2020B firmware, and to the Model 2491 Device Data Management Application (DDMA).
P010030/S051
7/14/14
Real-Time
LifeVest® Wearable Defibrillator ZOLL Lifecor Corporation
Pittsburgh, PA 15238
Approval for a software change that will enable an analog clipping noise detector which will allow the system to better recognize when an input signal may be compromised due to saturation of analog amplifiers in the ECG signal processing circuitry.
P010031/S414
7/9/14
180-Day
Concerto II CRT-D, Maximo II CRT-D,
Consulta CRT-D, Consulta CRT-D DF4, Maximo II CRT-D DF4
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Medtronic Viva CRT-P Model C6TR01 Implantable Pacemaker with Cardiac Resynchronization; Programmer Software Application Model 9995 v8.3; and updates to the Medtronic CareLink Monitor Model 2490G, CardioSight Reader Model 2020A and CareLink Express Model 2020B firmware, and to the Model 2491 Device Data Management Application (DDMA).
P010031/S442
7/3/14
180-Day
Viva/Brava Quadripolar
CRT-Ds
Medtronic, Inc.
Mounds View, MN 55112
Approval for the Viva/Brava Quadripolar Cardiac Resynchronization Therapy Defibrillator   (CRT-D) devices and is indicated for patients who require ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life- threatening ventricular arrhythmias, for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias and for providing cardiac resynchronization therapy in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the classifications provided in the labeling.
P010032/S075
7/2/14
180-Day
Eon Mini and Protégé Implantable Neurostimulation Systems St. Jude Medical
Plano, Texas
75024
Approval for hardware and software modifications to the Eon Charging System Model 3726.
P010032/S078
7/7/14
Real-Time
Eon Mini and Protégé Implantable Neurostimulation Systems St. Jude Medical Implantable Electronic Systems
Plano, TX
75024
Approval for updating firmware from version 3.0 to version 3.0.1 for Eon Mini (Model 3788) and Protégé (Model 2789) Implantable Pulse Generator that are used in Spinal Cord Stimulation therapy.
P010032/S079
7/14/14
Real-Time
Protégé Implantable Neurostimulation Systems St. Jude Medical Implantable Electronic Systems
Plano, TX
75024
Approval for Rapid Programmer version 3.6 to support the programming of the Protégé neurostimulation devices (Model 3789 Protégé implantable pulse generator and Model 3852 patient programmer) as well as to make minor sustaining enhancements.
P010055/S009
7/30/14
180-Day
ProstaLund CoreTherm System and ProstaLund CoreTherm Accessories ProstaLund Operation AB
Lund, Sweden
SE-223
Approval for a manufacturing site located at Orifice Medical AB in Ystad, Sweden.
P010062/S008
7/28/14
180-Day
Boston® Orthokeratology (Oprifocon A) Shaping Lens Bausch & Lomb
Rochester, NY 14609
Approval for a labeling update to the Package Insert and Patient Information Booklet to include the results from a Section 522 Postmarket Surveillance Study (PAS).
P010068/S039
7/2/14
135-Day
Celsius DS, NaviStar DS, NaviStar RMT DS, EZ Steer Nav DS Catheters Biosense Webster, Inc.
Diamond Bar, CA 91765
Approval for applying a change in sterilization release method to the new line of catheters at the Santa Teresa, New Mexico facility.
P020045/S054
7/17/14
Real-Time
Freezor Cardiac CryoAblation System Medtronic CryoCath LP
Quebec, Canada
H9R 5Z8
Approval for modifications to the Y-block distal diameter and the adhesive used in the Y-block to Shaft bond.
P030011/S024
7/2/14
180-Day
SynCardia temporary Total Artificial Heart (TAH-t) System SynCardia Systems, Inc.
Tucson, AZ
85713
Approval for use of the SynHall valve in the SynCardia temporary Total Artificial Heart (TAH-t).
P030031/S044
7/1/14
180-Day
Navistar RMT Thermocool Catheter Biosense Webster, Inc.
Diamond Bar, CA 91765
Approval for a manufacturing site located at Biosense Webster, Inc., in Chihuahua, Mexico.
P030054/S268
7/24/14
Real-Time
FAMILY OF MERLIN@HOME TRANSMITTERS St. Jude Medical
Sunnyvale, CA 94085
Approval for cybersecurity updates to the Merlin@Home transmitters.
P040002/S048
7/14/14
Real-Time
AFX Bifurcated Stent Graft Delivery System Endologix, Inc.
Irvine, CA
92618
Approval for changes to the retraction stop on the inner core of the AFX Bifurcated Stent Graft Delivery System.
P040002/S049
7/30/14
Real-Time
AFX Endovascular AAA System Endologix, Inc.
Irvine, CA
92618
Approval to modify the anchor bonding process of the front tip subassembly on the AFX Accessory Stent Graft Delivery System.
P040013/S018
7/11/14
Special
GEM 21S (GROWTH-FACTOR ENHANCED MATRIX) Luitpold Pharmaceuticals, Inc.
Norristown, PA 19403
Approval for the revision of the GEM 21S package insert.
P040033/S027
7/30/14
Real-Time
Birmingham Hip Resurfacing (BHR) System Smith & Nephew Orthopaedics
Cordova, TN
38016
Approval for an instrument to assist in femoral component sizing and positioning.
P040036/S032
7/1/14
180-Day
Celsius RMT Thermocool Catheter Biosense Webster, Inc.
Diamond Bar, CA 91765
Approval for a manufacturing site located at Biosense Webster, Inc., in Chihuahua, Mexico.
P040044/S056
7/30/14
180-Day
Mynx Vascular Closure Device Product Family Access Closure, Inc.
Santa Clara, CA 95054
Approval to expand the indications for use to include closure of venous access sites in addition to the currently approved use for closure of arterial access sites. The device, as modified, will be marketed under the trade name MynxGrip Vascular Closure Device and is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.
P050010/S013
7/31/14
180-Day
PRODISC L Total Disc Replacement DePuy Synthes Spine
Raynham, MA 02767
Approval for modified labeling to reflect findings of the post-approval study (PAS).
P050023/S076
7/3/14
180-Day
Ilesto/Iforia DF4 ICDs/CRT-Ds Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the DF4 variants of the currently approved Ilesto/Iforia ICDs/CRT-Ds and LinoxSmart ICD leads.
P050031/S001
7/28/14
180-Day
Paragon Z CRT® Lens Paragon Vision Sciences, Inc.
Mesa, AZ
85204
Approval for a labeling update to the Package Insert and Patient Information Booklet to include the results from a Section 522 Postmarket Surveillance Study (PAS).
P050033/S016
7/17/14
Real-Time
Hydrelle Anika Therapeutics Incorporated
Bedford, MA
01730
Approval for changes to the stability protocol.
P050053/S015
7/24/14
180-Day
INFUSE® Bone Graft and INFUSE® Bone GraftLT-Cage Lumbar Tapered Fusion Device Medtronic Spinal
Memphis, TN
38132
Approval for a manufacturing site located at Wyeth Farma, S.A, in De Los Reyes, Spain.
P060025/S013
7/30/14
180-Day
Medtronic 3f Aortic Bioprosthesis Medtronic Structural Heart
Santa Ana, CA 92705
Approval for a manufacturing site located at Medtronic in Santa Ana, California.
P060037/S026
7/18/14
180-Day
NexGen Complete Knee Solution, Legacy Knee – Posteriorly Stabilized (LPS), and LPS-Flex Mobile Bearing Knee Zimmer, Inc.
Warsaw, IN
46581
Approval for a manufacturing site located at Synergy Health located in  Daniken, Switzerland.
P060038/S020
7/15/14
180-Day
MitroFlow Aortic Pericardial Heart Valve (MAPHV™) Sorin Group USA, Inc.
Canada
V5J 5M1
Approval of the post-approval study protocol.
P060040/S036
7/27/14
Real-Time
Thoratec HeartMate II Left Ventricular Assist Device Thoratec Corporation
Pleasanton, CA 94588
Approval for software changes to the Backup Application of the Pocket Controller.
P070014/S044
7/18/14
180-Day
Bard® LifeStent® Vascular Stent System Bard Peripheral Vascular, Inc.
Tempe, AZ
85280
Approval for a smaller stent diameter (5mm) with an identical design/cut pattern to the current LifeStent.
P070014/S045
7/11/14
180-Day
LifeStent Vascular Stent Systems Bard Peripheral Vascular, Inc.
Tempe, AZ
85280
Approval of the post-approval study protocol.
P070027/S039
7/16/14
180-Day
Talent Converter Stent Graft System & Talent Occluder System Medtronic Vascular
Santa Rosa, CA 95403
Approval of the post-approval study protocol.
P080011/S030
7/8/14
135-Day
CooperVision Comfilcon A Soft Extended-Wear Contact Lenses CooperVision, Inc.
Pleasanton, CA 94588
Approval for a new manufacturing line at the Puerto Rico facility.
P080025/S074
7/25/14
Special
InterStim Therapy for Bowel Control Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for changes to the labeling to add a warning regarding the risk of increased or uncontrolled bleeding and the use of anticoagulants prior to surgery for InterStim Therapy.
P100003/S004
7/16/14
180-Day
SECURE®-C Artificial Cervical Disc Globus Medical, Inc.
Audobon, PA
19403
Approval of the post-approval study protocol.
P100009/S004
7/9/14
Real-Time
MitraClip Clip Delivery System Abbott Vascular
Menlo Park, CA 94025
Approval for a new patient brochure.
P100021/S038
7/8/14
Special
Endurant and Endurant II Stent Graft System Medtronic Vascular
Santa Rosa, CA 95403
Approval for introducing a lamp mandrel as a manufacturing tool for radiopaque contralateral gate marker inspection of Endurant and Endurant II Bifurcated Stent Grafts and a coil dispenser as a visual aid during the pre-kitting process of Endurant II Stent Grafts.
P100026/S017
7/9/14
Real-Time
RNS® System NeuroPace, Inc.
Mountain View, CA 94043
Approval to use 20 micron thick separators in the QMR model 2570 battery.
P100027/S018
7/30/14
Real-Time
INFORM HER2 Dual ISH DNA Probe Cocktail System Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for the extension of stability dating for the INFORM HER2 Dual ISH DNA Probe Cocktail system, which includes the following products: INFORM HER2 Dual ISH DNA Probe Cocktail, ultraView Red ISH DIG Detection Kit, ultraView SISH DNP Detection Kit.
P100030/S004
7/31/14
180-Day
PreveLeak Surgical Sealant Tenaxis Medical, Inc.
Mountain View, CA 94043
Approval for a product trade name change from ArterX® Surgical Sealant to PreveLeak Surgical Sealant. The device, as modified, will be marketed under the trade name PreveLeak Surgical Sealant and is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
P100034/S008
7/24/14
180-Day
NovoTTF-100A System NovoCure, Ltd.
Rye Beach, NH
03871
Approval for 1) design changes to the NovoTTF-100A connection cable to enhance its durability and 2) the addition of UNIXTAR Technology, Inc. as a second source supplier of the connection cables.
P100034/S009
7/25/14
Real-Time
NovoTTF-l00A System NovoCure, Ltd.
Rye Beach, NH
03871
Approval to replace the current Tyvek pouch packaging material for the INE transducer arrays with an aluminum foil moisture barrier and to extend the shelf life for these transducer arrays from 6 to 9 months.
P100049/S010
7/22/14
Special
Linx Reflux Management System Torax Medical, Inc.
Shoreview, MN 55126
Approval for labeling alterations including adverse event information about erosion of the LINX device, clarifications or contraindications regarding nickel, warnings regarding storage and use above 60 degrees C, additional potential risk of saliva/mucus build-up, and directions which add the removal of sutures after the clasp ends are fully engaged.
P110002/S005
7/15/14
180-Day
Mobi-C Cervical Disc LDR Spine USA, Inc.
Austin, TX
78750
Approval of the post-approval study protocol.
P110009/S005
7/15/14
180-Day
Mobi-C Cervical Disc LDR Spine USA, Inc.
Austin, TX
78750
Approval of the post-approval study protocol.
P110010/S083
7/18/14
Real-Time
PROMUS Element™ Plus and Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™ and Over-The-Wire) Boston Scientific Corporation
Maple Grove, MN 55311
Approval for the extension of the shelf life from 12 months to 18 months.
P110019/S063
7/3/14
135-Day
XIENCE PRIME® Everolimus Eluting Coronary Stent System, XIENCE XPEDITION™ Everolimus Eluting Coronary Stent System Abbott Vascular
Temecula, CA 92591
Approval to remove a stent inspection step.
P110019/S068
7/3/14
Real-Time
XIENCE Xpedition™ Everoliums Eluting Coronary Stent System, XIENCE Xpedition™ LL Everolimus Eluting Coronary Stent System, XIENCE Xpedition™ SV Everolimus Eluting Coronary Stent System Abbott Vascular
Temecula, CA 92591
Approval to change the outer layer thickness specification for the inner member catheter component for the Xience Xpedition, Xience Xpedition SV, and Xience Xpedition LL Everolimus Eluting Coronary Stent Over the Wire (OTW) System.
P110033/S002
7/30/14
135-Day
JUVÉDERM VOLUMA XC Allergan
Goleta, CA
93117
Approval for increased dryer capacity in JUVÉDERM VOLUMA XC manufacturing.
P120005/S019
7/11/14
Real-Time
Dexcom G4™ PLATINUM Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Approval for a change to the transmitter that combines the components from two printed circuit board assemblies (PCBAs) into a single board transmitter (SBT) with one printed circuit board (PCB).
P120010/S021
7/10/14
Real-Time
MiniMed 530G System Medtronic Minimed
Northridge, CA 91325
Approval to lower the purity specification limit for the Chromium layer on Enlite™ Glucose Sensor (MMT-7008) of the MiniMed 530G System and Sof™ Glucose Sensor (MMT-7002, MMT-7003) of the Paradigm REAL-Time Revel System.
P120020/S004
7/10/14
135-Day
Supera Peripheral Stent System Abbott Vascular
Santa Clara, CA 95054
Approval for implementation of a semi-automated passivation process and a change to the passivation of stent couplings by an alternate vendor.
P130016/S002
7/1/14
Real-Time
Nucleus® Hybrid™ Implant System Cochlear Americas
Centennial, CO 80111
Approval for an MR indication at 1.5 tesla under specific scanning conditions with the magnet surgically removed prior to the MR scan, for the Hybrid L24 Implant System.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P790007/S042
7/23/14
Hancock® Modified Orifice Valved Conduit Medtronic, Inc.
Santa Ana, CA 92705
Addition of a new porcine tissue supplier.
P830060/S080
7/30/14
VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM Boston Scientific Corporation
St. Paul, MN
55112
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the  devices.
P830061/S109
7/16/14
CAPSURE SENSE LEADS Medtronic, Inc.
Mounds View, MN 55112
Implementation of an equivalent sterilizer and aerator.
P840001/S270
7/2/14
RestoreSensor Rechareable Neurostimulator, RestoreSensor SureScan
MRI Rechareable Neurostimulator
Medtronic Neuromodulation
Minneapolis, MN 55432
Update to the process flow at the IC Supplier.
P840001/S271
7/3/14
ITREL, RESTORE, and SYNERGY SYSTEMS Medtronic Neuromodulation
Minneapolis, MN 55432
Manufacturing change associated with incoming inspection activities.
P840001/S272
7/17/14
ITREL,RESTORE, and SYNERGY SYSTEMS Medtronic Neuromodulation
Minneapolis, MN 55432
Use alternate lasers for the laser bonding process.
P840001/S274
7/22/14
SCS Neurostimulators Implantable Restore Family Medtronic Neuromodulation
Minneapolis, MN 55432
Use a new software test package.
P860004/S208
7/3/14
SYNCHROMED SYSTEM Medtronic Neuromodulation
Minneapolis, MN 55432
Manufacturing change associated with incoming inspection activities.
P860004/S209
7/24/14
SYNCHROMED SYSTEM Medtronic Neuromodulation
Minneapolis, MN 55432
Manufacturing line move on the same Chaska, Minnesota campus, change in the inspection assembly process, removal of a cleaning step, and will discontinuing a manual fingerpull test.
P870078/S026
7/23/14
Hancock® Low Porosity Valved Conduit Medtronic, Inc.
Santa Ana, CA 92705
Addition of a new porcine tissue supplier.
P880086/S244
7/9/14
Accent SR RF, Accent DR RF St. Jude Medical
Sylmar, CA
91342
Modify the Device Post Sterilization Test (DPST) at ATE for the RF telemetry of the devices.
P900033/S037
7/3/14
INTEGRA Artificial Skin Dermal Regeneration Template Integra Life Sciences Corporation
Plainsboro, NJ 08536
Change in the Cleaning Validation to extend the Dirty hold time of Tanks TK-01 and TK-02 used in the Wet Processing Formulation.
P900056/S140
7/24/14
Rotablator Rotational Atherectomy System Boston Scientific Corporation
Maple Grove MN 55311
Change to the device component quality inspection process.
P910023/S340
7/10/14
Current+, Ellipse, Fortify, and Fortify Assura Families of ICD Devices St. Jude Medical, Sylmar, CA
91342
Change in the temperature cycling range for hybrid assemblies.
P910023/S341
7/18/14
Fortify and Fortify Assura families of ICD devices St. Jude Medical, Sylmar, CA
91342
Modification to the connector reinforcement process for hybrid assemblies.
P910073/S127
7/30/14
ENDOTAK LEAD SYSTEM Boston Scientific Corporation
St. Paul, MN
55112
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the  devices.
P910077/S145
7/30/14
VENTAK PRX AND VENTAK MINI Boston Scientific Corporation
St. Paul, MN
55112
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the  devices.
P920015/S132
7/10/14
Sprint Quattro Lead Medtronic CRDM
Mounds View, MN 55112
Modified testing frequency for the destructive pull test of the devices.
P920015/S134
7/28/14
Sprint Quattro Lead Medtronic CRDM
Mounds View, MN 55112
Addition of an alternate supplier for manufacture of the bifilar electrode coil for the devices.
P920048/S008
7/24/14
Rapid fFN Control Kit Hologic, Inc.
Sunnyvale, CA 94089
Change to add an intermediate solution in the manufacturing process of Positive Reference Calibrator, to modify the personnel in charge of in-process manufacturing testing and to increase the number of replicates in bulk solution concentration verification procedure for both Positive Reference Calibrator and Positive Control. The Positive Reference Calibrator and the Positive Control are components of the Rapid fFN Control kit for use with the TLiIQ Analyzer and fFN ELISA Test.
P930014/S073
7/16/14
AcrySof Intraocular Lenses Alcon Research, Ltd.
Fort Worth, TX 76134
Addition of an alternate component supplier.
P930035/S027
7/30/14
VENTAK P2 PACEMAKER Boston Scientific Corporation
St. Paul, MN
55112
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the  devices.
P930039/S110
7/8/14
CapSureFix Novus Lead Medtronic, Inc.
Mounds View MN, 55112
Add a helix linearity inspection at the final functional inspection and a helix linearity fixture to facilitate this linearity inspection.
P930039/S111
7/16/14
CAPSUREFIX NOVUS LEADS Medtronic, Inc.
Mounds View, MN 55112
Implementation of an equivalent sterilizer and aerator.
P950001/S027
7/30/14
SELUTE LEAD SYSTEM Boston Scientific Corporation
St. Paul, MN
55112
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the  devices.
P950029/S091
7/16/14
Reply SR, Reply DR, Esprit SR, Esprit DR Sorin CRM USA, Inc
Arvada, CO
80004
Change to the in-process verifications for tantalum capacitors used in the devices.
P950029/S092
7/28/14
Reply SR, Reply DR, Esprit SR, Esprit DR Sorin CRM USA, Inc
Arvada, CO
80004
Change to a single pass process for screen printing and reflow soldering.
P950037/S136
7/11/14
Selox, TILDA, Solox Leads Biotronik, Inc.
Lake Oswego, OR 97035
Additional supplier for the conductor wires used in the manufacture of the leads.
P960004/S066
7/30/14
THIN/LINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS Boston Scientific Corporation
St. Paul, MN
55112
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the  devices.
P960006/S043
7/30/14
SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEADS Boston Scientific Corporation
St. Paul, MN
55112
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the  devices.
P960009/S196
7/3/14
ACTIVA, KINETRA, SOLETRA SYSTEMS Medtronic Neuromodulation
Minneapolis, MN 55432
Manufacturing change associated with incoming inspection activities.
P960040/S319
7/8/14
INCEPTA, ENERGEN, PUNCTUA, TELIGEN, VITALITY,
DYNAGEN, INOGEN, ORIGEN IMPLANTABLE CARDIOVERTER
DEFIBRILLATORS
Boston Scientific
St. Paul, MN
55112
Add a functionally equivalent sterilization chamber; 2) add a third Abator to be used with the additional sterilizer; and 3) include sterilizer chamber enhancements required for the existing and additional sterilizer chambers.
P960040/S321
7/11/14
ORIGEN™ EL ICD; INOGEN™ EL ICD; DYNAGEN™ EL ICD; ORIGEN™ MINI ICD; INOGEN™ MINI ICD; DYNAGEN™ MINI ICD Boston Scientific
St. Paul, MN
55112
Add the laser etched scratches inspection criteria for the devices.
P960040/S322
7/8/14
PUNCTUA ICDs,
TELIGEN ICDs,  
INCEPTA ICDs, ORIGEN ICDs, DYNAGEN ICDs
Boston Scientific Corporation
St. Paul, MN
55112
Add a replacement automated optical (AOI) inspection equipment for device identification and torque wrench verification.
P960040/S323
7/30/14
ICD ORIGEN,
ICD INOGEN,
ICD DYNAGEN,
ICD PUNCTUA, ICD TELIGEN,
ICD ENERGEN, ICD INCEPTA, ICD VITALITY
Boston Scientific Corporation
St. Paul, MN
55112
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the  devices.
P960040/S324
7/28/14
DYNAGEN™ EL ICD; INOGEN™ EL ICD; ORIGEN™ EL ICD; DYNAGEN™ MINI ICD;
NOGEN™ MINI ICD; ORIGEN™ MINI ICD
Boston Scientific Corporation
St. Paul, MN
55112
Blister sealer process setting changes for the devices.
N970003/S165
7/8/14
INSIGNIA, ALTRUA, INGENIO, ADVANTIO, VITALIO, FORMIO
PACEMAKERS
Boston Scientific
St. Paul, MN
55112
Add a functionally equivalent sterilization chamber; 2) add a third Abator to be used with the additional sterilizer; and 3) include sterilizer chamber enhancements required for the existing and additional sterilizer chambers.
N970003/S166
7/30/14
PG INSIGNIA, PG ADVANTIO, PG INGENIO,
PG VITALIO, PG FORMIO, PG ALTRUA
Boston Scientific Corporation
St. Paul, MN
55112
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the  devices.
P970003/S172
7/17/14
VNS Therapy System Cyberonics, Inc.
Houston, TX
77058
Automate a weld angle measurement process.
P970004/S176
7/2/14
SNS Urinary Verify Screening Trialing Systems (including Temporary
Leads)
Medtronic Neuromodulation
Minneapolis, MN 55432
Update to the process flow at the IC Supplier.
P970004/S177
7/3/14
SNS Urinary Extensions, SNS Urinary Leads Medtronic Neuromodulation
Minneapolis, MN 55432
Manufacturing change associated with incoming inspection activities.
P970004/S179
7/30/14
Medtronic Verify External Neurostimulator (ENS) Medtronic Neuromodulation
Minneapolis, MN 55432
Acceptance to expand the manufacturing acceptance criterion.
P970031/S046
7/23/14
Freestyle® Aortic Root Bioprosthesis Medtronic, Inc.
Santa Ana, CA 92705
Addition of a new porcine tissue supplier.
P980016/S486
7/11/14
Marquis DR ICD; Marquis VR ICD; Maximo DR ICD; Maximo VR ICD Medtronic CRDM
Mounds View, MN 55112
Supplier change and specification update to p(ETFE) used in Medtronic CRDM lithium-organic electrolyte batteries.
P980016/S487
7/17/14
Maximo II, Protecta, Protecta XT, Secura, Virtuoso II DR/VR ICDs Medtronic CRDM
Mounds View, MN 55112
Change in the epoxy dispense process for the devices.
P980016/S488
7/9/14
Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD;
Maximo II ICD; Protecta ICD; Protecta XT ICD;
Secura ICD; Virtuoso II DR/VR ICD
Medtronic CRDM
Mounds View, MN 55112
Reduction of Sonoscan detection method for the devices.
P980016/S490
7/30/14
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR
ICD
Medtronic CRDM
Mounds View, MN 55112
Additional equipment for the fill hole seal weld for the high voltage capacitor.
P980016/S491
7/22/14
Evera S DR/VR, Evera XT DR/VR, Maximo II, Protecta, Secura, Virtuoso DR/VR ICDs Medtronic CRDM
Mounds View, MN 55112
Modification on laser seam welder equipment at a final device manufacturing facility for the devices.
P980022/S157
7/18/14
Paradigm REAL-Time Revel System Medtronic MiniMed Inc.
Northridge, CA, 91325
Addition of a functional test during manufacture of the MySentry System (MMT-9100). The MySentry System (MMT-9100) consists of the MySentry Monitor (MMT-9101) and MySentry Outpost (MMT-9102) and is approved for use with the Paradigm REALTime Revel System.
P980022/S158
7/24/14
Paradigm® REAL-Time System and Paradigm® REAL-Time Revel System Medtronic MiniMed Inc.
Northridge, CA 91325
Change in the concentration of a raw material used during manufacture of the EnliteTM Glucose Sensor (MMT-7008) of the MiniMed 530G System and SofTM Glucose Sensor (MMT-7002, MMT-7003) of the Paradigm® REAL-Time System and Paradigm® REAL-Time Revel System.
P980023/S059
7/11/14
LINOX SMART SD, VIGILA, VOLTA Biotronik, Inc.
Lake Oswego, OR 97035
Additional supplier for the conductor wires used in the manufacture of the leads.
P980024/S013
7/16/14
PathVysion HER-2 DNA Probe Kit Abbott Molecular, Inc.
Des Plaines, IL 60018
Modify the validated test method MDP00644 “Fragmented DNA Agarose Gel Electrophoresis” of the manufacturing process of Vysis ALK Break Apart FISH Probe Kit, PathVysion HER-2 DNA Probe Kit and UroVysion Bladder Cancer Kit.
P980035/S380
7/11/14
Advisa DR IPG; Advisa DR MRI IPG Medtronic, Inc.
Mounds View, MN 55112
Supplier change and specification update to p(ETFE) used in Medtronic CRDM lithium-organic electrolyte batteries.
P980035/S381
7/16/14
Adapta, Versa, Sensia IPG Medtronic, Inc.
Mounds View, MN 55112
Implementation of an equivalent sterilizer and aerator.
P980035/S383
7/28/14
Adapta, Versa, Sensia IPG Medtronic, Inc.
Mounds View, MN 55112
Update to seam weld parameters for the devices.
P980043/S046
7/11/14
Hancock® II Porcine Bioprosthesis Medtronic, Inc.
Santa Ana, CA 92705
Addition of a new sewing machine for use with the cloth cover.
P980043/S047
7/23/14
Hancock® II Porcine Bioprosthesis Medtronic, Inc.
Santa Ana, CA 92705
Addition of a new porcine tissue supplier.
P980049/S100
7/16/14
Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR, Paradym RF VR, Paradym RF DR Sorin CRM USA, Inc
Arvada, CO
80004
Change to the in-process verifications for tantalum capacitors used in the devices.
P990034/S032
7/3/14
Drug Delivery Catheters, Drug Delivery Kits for Revisions Medtronic Neuromodulation
Minneapolis, MN 55432
Manufacturing change associated with incoming inspection activities.
P990064/S055
7/11/14
Mosaic® Porcine Bioprosthesis Medtronic, Inc.
Santa Ana, CA 92705
Addition of a new sewing machine for use with the cloth cover.
P990064/S056
7/23/14
Mosaic® Porcine Bioprosthesis Medtronic, Inc.
Santa Ana, CA 92705
Addition of a new porcine tissue supplier.
P000029/S078
7/31/14
Deflux Injectable Gel Salix Pharmaceuticals, Inc.
Raleigh, NC
27615
Qualify an alternate supplier of the ready-prepared solutions of NaOH and HCL used for the manufacturing of Deflux device.
P000046/S025
7/8/14
Staarvisc, Optivisc, NuVisc, Anikavisc Sodium Hyaluronate Anika Therapeutics, Inc.
Bedford, MA
01730
Change to the syringe residual solvent testing from a supplier’s contract laboratory to the supplier’s in-house facility for Anika’s ophthalmic devices.
P010012/S358
7/8/14
INCEPTA, ENERGEN, PUNCTUA, COGNIS, DYNAGEN, INOGEN, ORIGEN CRT-DEFIBRILLATORS Boston Scientific
St. Paul, MN
55112
Add a functionally equivalent sterilization chamber; 2) add a third Abator to be used with the additional sterilizer; and 3) include sterilizer chamber enhancements required for the existing and additional sterilizer chambers.
P010012/S360
7/11/14
DYNAGEN™ CRT-D; DYNAGEN™ X4 CRT-D; INOGEN™ CRT-D; INOGEN™ X4 CRT-D; ORIGEN™ CRT-D; ORIGEN™ X4 CRT-D Boston Scientific
St. Paul, MN
55112
Add the laser etched scratches inspection criteria for the devices.
P010012/S361
7/8/14
PUNCTUA CRT-Ds, ENERGEN CRT-Ds, INCEPTA CRT-Ds, ORIGEN CRT-Ds, INOGEN CRT-Ds, DYNAGEN
CRT-Ds
Boston Scientific Corporation
St. Paul, MN
55112
Add a replacement automated optical (AOI) inspection equipment for device identification and torque wrench verification.
P010012/S362
7/9/14
EASYTRAK 2 IS-1 Coronary Venous Pace/Sense Leads Boston Scientific Corporation
St. Paul, MN
55112
Extend the expiration term for plasma treatment and to add a process monitor.
P010012/S363
7/30/14
ACCESSORY,
ORIGEN CRT-D,
INOGEN CRT-D,
DYNAGEN
CRT-D, PUNCTUA CRT-D; ENERGEN CRT-D; INCEPTA CRT-D
Boston Scientific Corporation
St. Paul, MN
55112
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the  devices.
P010012/S364
7/28/14
DYNAGEN™ CRT-D DYNAGEN™ X4 CRT-DG; INOGEN™ CRT-D; INOGEN™ X4 CRT-D; ORIGEN™ CRT-D; ORIGEN™ X4 CRT-D Boston Scientific Corporation
St. Paul, MN
55112
Blister sealer process setting changes for the devices.
P010015/S241
7/11/14
Consulta CRT-P; Syncra CRT-P Medtronic, Inc.
Mounds View, MN 55112
Supplier change and specification update to p(ETFE) used in Medtronic CRDM lithium-organic electrolyte batteries.
P010015/S243
7/24/14
Viva CRT-P Medtronic, Inc.
Mounds View, MN 55112
Manufacturing changes to align the production of Viva CRT-P with existing market approved products.
P010031/S448
7/11/14
InSync III Marquis ICD; InSync Maximo ICD Medtronic, Inc.
Mounds View, MN 55112
Supplier change and specification update to p(ETFE) used in Medtronic CRDM lithium-organic electrolyte batteries.
P010031/S449
7/17/14
Concerto II, Maximo II, Protecta, Protecta XT CRT-Ds, Consulta ICDs Medtronic CRDM
Mounds View, MN 55112
Change in the epoxy dispense process for the devices.
P010031/S450
7/9/14
Brava CRT-D; Concerto II CRT-D;
Consulta ICD; Maximo II CRT-D; Protecta CRT-D; Protecta XT
CRT-D;  Viva S CRT-D; Viva XT CRT-D
Medtronic CRDM
Mounds View, MN 55112
Reduction of Sonoscan detection method for the devices.
P010031/S452
7/30/14
Brava CRT-D, Viva S CRT-D, Viva XT CRT-D Medtronic CRDM
Mounds View, MN 55112
Additional equipment for the fill hole seal weld for the high voltage capacitor.
P010031/S453
7/24/14
Brava Quad, Viva Quad C, Viva Quad S, Viva Quad XT CRT-Ds Medtronic, Inc.
Mounds View, MN 55112
Manufacturing changes to align the production of Viva and Brava models with existing market approved products.
P010031/S454
7/22/14
Brava, Brava Quad, Concerto II, Consulta, Maximo II, Protecta, Protecta XT, Viva Quad S/XT, Viva S/XT CRTDs Medtronic CRDM
Mounds View, MN 55112
Modification on laser seam welder equipment at a final device manufacturing facility for the devices.
P010032/S082
7/17/14
Eon Implantable Pulse Generator,
Eon Mini Implantable Pulse Generator, Protégé Implantable Pulse Generator
St. Jude Medical
Neuromodulation
Plano, Texas
75024
Upgrade the welding equipment used in a manufacturing process.
P010047/S035
7/2/14
Progel® Pleural Air Leak Sealant Neomend, Inc.
Irvine, CA
92618
Alternate Extended Applicator Spray Tip supplier.
P020004/S098
7/2/14
Excluder AAA Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of Fourier Transform Infrared Spectroscopy, Bacterial Endotoxin Testing, Heavy Metals as Lead (HMAL) and Non-Volatile Residue (NVR) testing in the East Coast Testing Center.
P020004/S099
7/2/14
EXCLUDER® AAA Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of an alternate bioburden extraction method and updating existing documents to allow for use of alternative/ additional organism strains and/or removal of specific microorganism strain designations and updated nomenclature in accordance with USP <61> and USP <62>.
P020004/S100
7/2/14
Excluder AAA Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Updated hardware and software for FTIR spectrophotometer computers.
P020004/S101
7/2/14
Excluder® AAA Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of an additional moisture analyzer and implementation of additional functionality of the analyzer.
P020004/S102
7/21/14
Excluder® AAA Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
New tooling used in a molding process, replication of the molding process at an additional facility, and a new supplier of the molded component.
P020025/S062
7/14/14
BLAZER II XP CARDIAC ABLATION CATHETER-IntellaTip MiFi Filter Module, IntellaTip MiFi Reference Cable Boston Scientific Corporation
San Jose, CA
95134
Update to the current Manufacturing Execution System (MES).
P020025/S063
7/18/14
IntellaTip MiFi XP Temperature Ablation Catheter Boston Scientific Corporation
San Jose, CA
95134
Manufacturing change of the final electrical inspection test method.
P020045/S056
7/9/14
Freezor Cardiac CryoAblation System Medtronic CryoCath LP
Quebec, Canada
H9R 5Z8
Addition of an inspection procedure for the Low Pressure Regulator during manufacturing, as well as the replacement of an analog pressure gauge used during installation and maintenance with a digital one.
P020045/S058
7/25/14
FREEZOR CARDIAC CRYOABLATION CATHETER, XTRA SURGICAL CRYOABLATION CATHETER, MAX SURGICAL CARDIAC CRYOABLATION CATHETER-Coaxial Umbilical Cable Medtronic CryoCath LP
Mounds View, MN 55112
Alternate supplier for connectors and connector fittings and acceptance of an alternate adhesive curing process.
P030005/S111
7/8/14
INVIVE, CONTAK RENEWAL, INTUA CRT-PACEMAKERS Boston Scientific
St. Paul, MN
55112
Add a functionally equivalent sterilization chamber; 2) add a third Abator to be used with the additional sterilizer; and 3) include sterilizer chamber enhancements required for the existing and additional sterilizer chambers.
P030005/S112
7/30/14
INVIVE CRT-P,
INTUA CRT-P
Boston Scientific Corporation
St. Paul, MN
55112
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the  devices.
P030009/S079
7/31/14
Integrity Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403
Changes to the sub-assembly manufacturing process.
P030017/S200
7/11/14
Precision Spectra™ Spinal Cord Stimulator (SCS) System Boston Scientific Corporation Neuromodulation
Valencia, CA
91355
Alternate capacitor supplier.
P030019/S020
7/8/14
Staarvisc, Optivisc, NuVisc, Anikavisc Sodium Hyaluronate Anika Therapeutics, Inc.
Bedford, MA
01730
Change to the syringe residual solvent testing from a supplier’s contract laboratory to the supplier’s in-house facility for Anika’s ophthalmic devices.
P030019/S021
7/25/14
Orthovisc, High Molecular Weight Hyaluronan Anika Therapeutics, Inc.
Bedford, MA
01730
Changes in the manufacturing equipment.
P030035/S122
7/9/14
ANTHEM RF CRT-PS St. Jude Medical
Sylmar, CA
91342
Modify the Device Post Sterilization Test (DPST) at ATE for the RF telemetry of the devices.
P030052/S015
7/16/14
UroVysion Bladder Cancer Kit Abbott Molecular, Inc.
Des Plaines, IL 60018
Modify the validated test method MDP00644 “Fragmented DNA Agarose Gel Electrophoresis” of the manufacturing process of Vysis ALK Break Apart FISH Probe Kit, PathVysion HER-2 DNA Probe Kit and UroVysion Bladder Cancer Kit.
P030053/S018
7/30/14
Mentor MemoryGel Silicone Gel-Filled Breast Implants Mentor Worldwide LLC
Santa Barbara, CA 93111
Change to remove the in process Gel cohesion test that is performed during the manufacture of the Gel that is used to fill the Mentor MemoryGel Silicone Gel-Filled Breast Implants at Mentor's Irving, Texas facility.
P030054/S271
7/10/14
Promote+, Promote Quadra, Unify, Unify Quadra, Unify Assura, and Quadra Assura Families of CRT-D Devices St. Jude Medical, Sylmar, CA
91342
Change in the temperature cycling range for hybrid assemblies.
P030054/S272
7/18/14
Quadra Assura, Unify, Unify Assura, and Unify Quadra families of
CRT-D Devices
St. Jude Medical, Sylmar, CA
91342
Modification to the connector reinforcement process for hybrid assemblies.
P040002/S050
7/7/14
AFX Endovascular AAA System Endologix, Inc.
Irvine, CA
92618
Alternate supplier for the laser welding process for the delivery system inner core subassemblies.
P040002/S051
7/11/14
AFX Endovascular AAA System Endologix, Inc.
Irvine, CA
92618
Alternate polytetrafluoro- ethylene (PTFE) resin.
P040002/S052
7/9/14
AFX Endovascular AAA System Endologix, Inc.
Irvine, CA
92618
Alternate method for the heat-shrink process.
P040020/S054
7/16/14
AcrySof Intraocular Lenses Alcon Research, Ltd.
Fort Worth, TX 76134
Addition of an alternate component supplier.
P040024/S075
7/1/14
Restylane, Perlane, Restylane-L, and Perlane-L Injectable Gels Valeant Pharmaceuticals North America
Bridgewater, NJ 08807
Introduction of an intermediate storage system (ISS) in the manufacturing process used in Factory 2.
P040027/S034
7/2/14
VIATORR TIPS Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of Fourier Transform Infrared Spectroscopy, Bacterial Endotoxin Testing, Heavy Metals as Lead (HMAL) and Non-Volatile Residue (NVR) testing in the East Coast Testing Center.
P040027/S035
7/2/14
VIATORR® TIPS Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of an alternate bioburden extraction method and updating existing documents to allow for use of alternative/ additional organism strains and/or removal of specific microorganism strain designations and updated nomenclature in accordance with USP <61> and USP <62>.
P040027/S036
7/2/14
VIATORR TIPS Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Updated hardware and software for FTIR spectrophotometer computers.
P040027/S037
7/2/14
VIATORR® TIPS Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of an additional moisture analyzer and implementation of additional functionality of the analyzer.
P040037/S066
7/2/14
VIABAHN Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of Fourier Transform Infrared Spectroscopy, Bacterial Endotoxin Testing, Heavy Metals as Lead (HMAL) and Non-Volatile Residue (NVR) testing in the East Coast Testing Center.
P040037/S067
7/2/14
VIABAHN® Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of an alternate bioburden extraction method and updating existing documents to allow for use of alternative/ additional organism strains and/or removal of specific microorganism strain designations and updated nomenclature in accordance with USP <61> and USP <62>.
P040037/S068
7/2/14
VIABAHN Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Updated hardware and software for FTIR spectrophotometer computers.
P040037/S069
7/2/14
VIABAHN® Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of an additional moisture analyzer and implementation of additional functionality of the analyzer.
P040037/S070
7/31/14
GORE VIABAHN Endoprosthesis and VIABAHN with Heparin Bioactive Surface W.L. Gore & Associates
Phoenix, AZ
85085
Automation of the presentation and cutting process for catheter manufacturing and removal of related inspections.
P040043/S063
7/2/14
TAG Thoracic Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of Fourier Transform Infrared Spectroscopy, Bacterial Endotoxin Testing, Heavy Metals as Lead (HMAL) and Non-Volatile Residue (NVR) testing in the East Coast Testing Center.
P040043/S064
7/2/14
TAG® Thoracic Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of an alternate bioburden extraction method and updating existing documents to allow for use of alternative/ additional organism strains and/or removal of specific microorganism strain designations and updated nomenclature in accordance with USP <61> and USP <62>.
P040043/S065
7/2/14
TAG Thoracic Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Updated hardware and software for FTIR spectrophotometer computers.
P040043/S066
7/2/14
TAG® Thoracic Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of an additional moisture analyzer and implementation of additional functionality of the analyzer.
P040045/S045
7/23/14
VISTAKON Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256
Add a second supplier for the senofilcon A monomer used for manufacturing VISTAKON (senofilcon A) brand contact lenses.
P040047/S036
7/16/14
Coaptite Injectable Implant Merz North America, Inc.
Franksville, WI 53126
Changes to the sterilization process for the Coaptite Injectable Implant.
P050006/S039
7/2/14
HELEX Septal Occluder W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of Fourier Transform Infrared Spectroscopy, Bacterial Endotoxin Testing, Heavy Metals as Lead (HMAL) and Non-Volatile Residue (NVR) testing in the East Coast Testing Center.
P050006/S040
7/2/14
HELEX® Septal Occluder W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of an alternate bioburden extraction method and updating existing documents to allow for use of alternative/ additional organism strains and/or removal of specific microorganism strain designations and updated nomenclature in accordance with USP <61> and USP <62>.
P050006/S041
7/2/14
HELEX Septal Occluder W.L. Gore & Associates
Phoenix, AZ
85085
Updated hardware and software for FTIR spectrophotometer computers.
P050006/S042
7/2/14
HELEX® Septal Occluder W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of an additional moisture analyzer and implementation of additional functionality of the analyzer.
P050047/S039
7/9/14
Juvéderm Hyaluronate Gel Implants Allergan
Goleta, CA
93117
Removal of an in-process control test used during the manufacture of Juvéderm Hyaluronate Gel Implants.
P050047/S041
7/30/14
Juvederm Hyaluronate Gel Implants Allergan
Goleta, CA
93117
Change in the incoming inspection procedure for the Sodium Hyaluronate (NaHA) raw material.
P060001/S021
7/1/14
Protégé GPS and Protégé RX Carotid Stent System ev3 Inc.
Plymouth, MN 55441
Change from a manual to an automated stent cleaning process.
P060006/S063
7/18/14
Express SD Renal Monorail Premounted Stent System Boston Scientific Corp.
Maple Grove, MN 55311
Changing the manual inspection of a component weld to a semi-automated inspection.
P060027/S067
7/16/14
Paradym CRT-D, Paradym RF,
CRT-D, Paradym RF CRT-D
Sorin CRM USA, Inc
Arvada, CO
80004
Change to the in-process verifications for tantalum capacitors used in the devices.
P060040/S037
7/17/14
Thoratec® HeartMate II® LeftVentricular Assist System Thoratec Corporation
Pleasanton, CA 94588
Manufacturing process changes to the printed circuit board (PCB) of the device controller.
P070008/S052
7/11/14
Corox OTW, CELERITY Leads Biotronik, Inc.
Lake Oswego, OR 97035
Additional supplier for the conductor wires used in the manufacture of the leads.
P080025/S072
7/2/14
SNS Bowel Verify Screening Trialing Systems (including Temporary
Leads)
Medtronic Neuromodulation
Minneapolis, MN 55432
Update to the process flow at the IC Supplier.
P080025/S073
7/3/14
SNS Bowel, SNS Bowel Leads Medtronic Neuromodulation
Minneapolis, MN 55432
Manufacturing change associated with incoming inspection activities.
P080025/S075
7/30/14
Medtronic Verify External Neurostimulator (ENS) Medtronic Neuromodulation
Minneapolis, MN 55432
Acceptance to expand the manufacturing acceptance criterion.
P090012/S009
7/7/14
MelaFind MELA Sciences Incorporated
Irvington, NY 10533
Added 3rd Party operating system installation software to version registry; and Deployment of new software build and installation workstations.
P090013/S144
7/11/14
Revo MRI IPG Medtronic, Inc.
Mounds View, MN 55112
Supplier change and specification update to p(ETFE) used in Medtronic CRDM lithium-organic electrolyte batteries.
P090013/S145
7/8/14
CapSureFix MRI Lead Medtronic, Inc.
Mounds View MN, 55112
Add a helix linearity inspection at the final functional inspection and a helix linearity fixture to facilitate this linearity inspection.
P090013/S146
7/16/14
CAPSUREFIX MRI SURESCAN LEAD Medtronic, Inc.
Mounds View, MN 55112
Implementation of an equivalent sterilizer and aerator.
P090022/S023
7/9/14
SOFTEC HD Intraocular Lenses Lenstec, Inc.
Saint Petersburg, FL 33716
Add three component washers for the use in the final clean area and inspection department to reduce bioburden and endotoxin of the intraocular lenses.
P090026/S011
7/7/14
Access Hybritech p2PSA reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Modification to the Quality Control prefill and postfill reagent pack procedures.
P090031/S002
7/8/14
Staarvisc, Optivisc, NuVisc, Anikavisc Sodium Hyaluronate Anika Therapeutics, Inc.
Bedford, MA
01730
Change to the syringe residual solvent testing from a supplier’s contract laboratory to the supplier’s in-house facility for Anika’s ophthalmic devices.
P100009/S006
7/16/14
MitraClip System Abbott Vascular
Menlo Park, CA 94025
Second supplier, a change in the heat treatment process and establishment of a defined range of acceptable raw material hardness for the Actuator Coupler of the MitraClip Clip Delivery System.
P100010/S036
7/2/14
Artic Front® and Artic Front Advance™ Medtronic, Cryocath LP
Mounds View, MN 55112
New supplier, inspection change, and minor updates to the specification of the bellows component.
P100010/S038
7/9/14
Arctic Front CryoCatheter System Medtronic CryoCath LP
Quebec, Canada
H9R 5Z8
Addition of an inspection procedure for the Low Pressure Regulator during manufacturing, as well as the replacement of an analog pressure gauge used during installation and maintenance with a digital one.
P100010/S040
7/25/14
ARTIC FRONT CYROABLATION CATHETER, ARTIC FRONT ADVANCE CRYOABLATION CATHETER Medtronic CryoCath LP
Mounds View, MN 55112
Alternate supplier for connectors and connector fittings and acceptance of an alternate adhesive curing process.
P100026/S019
7/9/14
Neuropace RNS System NeuroPace, Inc.
Mountain View, CA 94043
Use a replacement detergent to clean certain parts.
P100042/S003
7/7/14
Aptima® HPV Assay Gen-Probe Incorporated
San Diego, CA 92121
Change to revise an internal control QC release test specification for the Aptima® HPV Assay.
P110002/S007
7/23/14
LDR Spine Mobi-C Cervical Disc Prosthesis for use at One Level LDR Spine USA Inc.
Austin, TX
78750
Add back-up equipment for the machining of the Mobi-C superior and inferior endplates.
P110009/S007
7/23/14
LDR Spine Mobi-C Cervical Disc Prosthesis for use at Two Levels LDR Spine USA Inc.
Austin, TX
78750
Add back-up equipment for the machining of the Mobi-C superior and inferior endplates.
P110012/S006
7/16/14
Vysis ALK Break Apart FISH Probe Kit Abbott Molecular, Inc.
Des Plaines, IL 60018
Modify the validated test method MDP00644 “Fragmented DNA Agarose Gel Electrophoresis” of the manufacturing process of Vysis ALK Break Apart FISH Probe Kit, PathVysion HER-2 DNA Probe Kit and UroVysion Bladder Cancer Kit.
P110013/S043
7/31/14
Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403
Changes to the sub-assembly manufacturing process.
P110023/S008
7/2/14
EverFlex Self-Expanding Peripheral Stent System ev3 Inc.
Plymouth, MN 55441
Allow internal production of a braid component for the EverFlex outer catheter.
P110023/S009
7/1/14
EverFlex Self-Expanding Peripheral Stent System ev3 Inc.
Plymouth, MN 55441
Change from a manual to an automated stent cleaning process.
P110033/S010
7/30/14
Juvederm Voluma XC Allergan
Goleta, CA
93117
Change in the incoming inspection procedure for the Sodium Hyaluronate (NaHA) raw material.
P120005/S022
7/10/14
Dexcom G4 PLATINUM Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Change to the conditioning step of manufacturing the sensor wire subcomponent of the G4 Sensor. The G4 Sensor is a component of the G4 PLATINUM Continuous Glucose Monitoring System.
P120005/S023
7/14/14
Dexcom G4 PLATINUM Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Changes to the shipping and storage temperature range specifications for two reagents used in the manufacture of the device.
P120005/S024
7/16/14
Dexcom G4™ PLATINUM Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Manufacturing process change for the sensor layer deposition process for the G4 PLATINUM Sensor. The G4 PLATINUM Sensor is a component of the Dexcom G4™ PLATINUM Continuous Glucose Monitoring System.
P120005/S025
7/24/14
Dexcom G4 PLATINUM Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Change in the manufacturing process of the transmitter packaging tray to increase mold capacity at their supplier. The transmitter is a component of the Dexcom G4 PLATINUM Continuous Glucose Monitoring System.
P120010/S025
7/2/14
MiniMed 530G System Medtronic MiniMed Inc.
Northridge, CA 91325
Change in the manufacturing process for the EnliteTM Glucose Sensor (Model Numbers: MMT-7008A, MMT-7008B) to add a new sensor fabrication configuration to include a 48-up sensor mask. The EnliteTM Glucose Sensor is a component of the MiniMed 530G System.
P120010/S027
7/24/14
MiniMed 530G System Medtronic MiniMed Inc.
Northridge, CA 91325
Change in the concentration of a raw material used during manufacture of the EnliteTM Glucose Sensor (MMT-7008) of the MiniMed 530G System and SofTM Glucose Sensor (MMT-7002, MMT-7003) of the Paradigm® REAL-Time System and Paradigm® REAL-Time Revel System.
P120010/S028
7/22/14
MiniMed 530G System Medtronic MiniMed Inc.
Northridge, CA 91325
Change to the needle hub assembly tooling which is used in the manufacture of the Enlite Sensor (MMT-7008). The Enlite Sensor (MMT-7008) is a component of the MiniMed 530G System.
P130006/S006
7/2/14
VIABAHN Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of Fourier Transform Infrared Spectroscopy, Bacterial Endotoxin Testing, Heavy Metals as Lead (HMAL) and Non-Volatile Residue (NVR) testing in the East Coast Testing Center.
P130006/S007
7/2/14
VIABAHN® Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of an alternate bioburden extraction method and updating existing documents to allow for use of alternative/ additional organism strains and/or removal of specific microorganism strain designations and updated nomenclature in accordance with USP <61> and USP <62>.
P130006/S008
7/2/14
VIABAHN Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Updated hardware and software for FTIR spectrophotometer computers.
P130006/S009
7/2/14
VIABAHN® Endoprosthesis W.L. Gore & Associates
Phoenix, AZ
85085
Implementation of an additional moisture analyzer and implementation of additional functionality of the analyzer.
P130006/S010
7/31/14
GORE VIABAHN Endoprosthesis and VIABAHN with Heparin Bioactive Surface W.L. Gore & Associates
Phoenix, AZ
85085
Automation of the presentation and cutting process for catheter manufacturing and removal of related inspections.

Summary of PMA Originals & Supplements Approved

  • Originals: 1
  • Supplements: 81

Summary of PMA Originals Under Review

  • Total Under Review: 50
  • Total Active: 24
  • Total On Hold: 26

Summary of PMA Supplements Under Review

  • Total Under Review: 522
  • Total Active: 424
  • Total On Hold: 128

Summary of All PMA Submissions

  • Received Originals: 4
  • Supplements: 99

Summary of PMA Supplement PMA Approval/Denial Decision Times

  • Number of Approvals: 81
  • Number of Denials: 0
  • Average Days Fr Receipt to Decision (Total Time): 200.4
  • Days FDA Time: 132.2 Days
  • Days MFR Time: 68.2 Days

Page Last Updated: 01/26/2016
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