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PMA Final Decisions for August 2011

Wed, 09/28/2011 - 9:30am
U.S. Food & Drug Administration

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.

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.

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P100044

8/11/11

Propel™ Intersect ENT Approval for the Propel™ sinus implant. This device is indicated for use in patients ≥ 18 years of age following ethmoid sinus surgery to maintain patency, thereby reducing the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids. The Propel™ sinus implant separates mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces edema.
P110012

8/26/11

Vysis ALK Break Apart FISH Probe Kit; Vysis Paraffin Pretreatment IV & Post Hybridization Wash Buffer Kit; ProbeChek ALK Negative Control Slides; and ProbeChek

ALK Positive Control Slides

Abbott Molecular, Inc.

Des Plaines, IL

60018

Approval for the Vysis ALK Break Apart FISH Probe Kit; Vysis Paraffin Pretreatment IV & Post Hybridization Wash Buffer Kit; ProbeChek ALK Negative Control Slides; and ProbeChek ALK Positive Control Slides. This device is indicated for:

The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin -embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens to aid in identifying those patients eligible for treatment with Xalkori® crizotinib). The test is for prescription use only.

The Vysis Paraffin Pretreatment IV & Post Hybridization Wash Buffer Kit is used to prepare paraffin-embedded lung cancer tissue sections fixed on positively charged slides for use in fluorescence in situ hybridization (FISH) with Vysis DNA FISH probes.

The ProbeChek ALK Negative Control Slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020). The ProbeChek ALK Negative Control Slides should be assayed in conjunction with the user's specimen slides according the package insert for the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020).

The ProbeChek ALK Positive Control Slides are intended for use as an assay control for appropriate hybridization conditions during routine use of the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020). The ProbeChek ALK Positive Control Slides should be· assayed in conjunction with the user's specimen slides according the package insert for the Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020).

P110020

8/17/11

cobas® 4800 BRAF V600 Mutation Test Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Approval for the cobas® 4800 BRAF V600 Mutation Test. This device is indicated for: The cobas® 4800 BRAF V600 Mutation Test is an in vitro diagnostic device intended for the qualitative detection of the BRAF V600E mutation in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. The cobas® 4800 BRAF V600 Mutation Test is a real-time PCR test on the cobas 4800 system, and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with vemurafenib.
APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P810002/S076

8/11/11

Real-Time

St. Jude Medical® Mechanical Heart Valve: SJM® Masters Series – PTFE Sewing Cuff St. Jude Medical

St. Paul, MN

55117

Approval for changes to the specification range for the courses per inch (CPI) and thickness of the PTFE fabric used in the construction of the PTFE sewing cuff used with the Masters Series Valves, as well as approval of two changes intended to offset the increase in the force required for valve rotation (torque) associated with the fabric modification. These proposed changes are for the increase in the diameter of the rotation spring and retainer ID and reducing the lower limit of torque from 2.0 in-oz to 0.2

in-oz.

P840001/S195

8/26/11

Special

RestorePrime, Prime Advanced, Restore, RestoreUltra, RestoreAdvanced, Itrel 3, Synergy, and Synergy Versitrel Implantable Neurostimulators (INS) Medtronic Neuromodulation

Minneapolis, MN 55432

Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition of precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.
P850022/S018

8/11/11

Real-Time

Biomet ® OrthoPak® Non-Invasive Bone Growth Stimulator System and the Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator System EBI, L.P.

Parsippany, NJ

07054

Approval for the modification of the system software to include an additional line of code which would allow the real-time clock to reset to “day zero” after an

elapsed 365 days. This reset would allow your device to remain functional after 365 days of

inactivity. The device, as modified, will be marketed under the trade names OrthoPak® Non-Invasive

Bone Growth Stimulator System and SpinalPak Non-Invasive Spine Fusion Stimulator

System and are indicated for the following:

1) The Biomet® OrthoPak® Non-Invasive Bone Growth Stimulator System is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half

the width of the bone to be treated. A nonunion is considered to be established when the

fracture site shows no visible progressive signs of healing; and

2) The Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator System is indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.

P860004/S157

8/26/11

Special

SynchroMed II and SynchroMed EL Implantable Infusion Pump Medtronic Neuromodulation

Minneapolis, MN 55432

Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition of precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.
P880006/S071

8/3/11

180-Day

Sensolog, Dialog and Regency Family of Pacemakers St. Jude Medical, Cardiac Rhythm Management

Sylmar, CA

91342

Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P880006/S072

8/17/11

Real-Time

St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices St. Jude Medical Cardiac Rhythm Management

Sunnyvale, CA

94086

Approval for minor modifications to the patient manuals packaged with the devices.
P880086/S198

8/2/11

135-Day

Affinity, Integrity, Victory, Zephyr and Accent Families of Pacemakers St. Jude Medical

Cardiac Rhythm Management

Sylmar, CA

91342

Approval for additional manufacturing screening tests for a device component.
P880086/S203

8/3/11

180-Day

Affinity, Integrity, Victory, Zephyr and Accent Family of Pacemakers St. Jude Medical, Cardiac Rhythm Management

Sylmar, CA

91342

Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P880086/S206

8/11/11

Real-Time

Accent Family of Pacemakers St. Jude Medical

Cardiac Rhythm Management

Sylmar, CA

91342

Approval for modifications to the hybrid used in the devices.
P880086/S207

8/17/11

Real-Time

St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices St. Jude Medical Cardiac Rhythm Management

Sunnyvale, CA

94086

Approval for minor modifications to the patient manuals packaged with the devices.
P890003/S228

8/25/11

Real-time

Medtronic CareLink Express Monitors Medtronic, Inc.

Mounds View, MN

55112

Approval for Models 2020B/C Medtronic CareLink Express Monitors and Modifications to the Model

2490G/H/J Medtronic CareLink Remote Home Monitor and Model 2020A Medtronic

CardioSight Reader to update device Firmware.

P890023/S017

8/9/11

135-Day

Biomedics UV 55% (Ocufilcon D) Sphere, Asphere and Toric Soft Contact Lens CooperVision

Pleasanton, CA

94588

Approval for an alternate vendor, BIMAX, for raw material.
P900056/S104

8/31/11

180-Day

Rotablator Rotational Atherectomy System

 

Boston Scientific Corporation

Maple Grove, MN

55311

Approval for modifications to the RotaWire and Rotalink Burr/ Rotalink Plus Instructions for Use (IFU).
P910023/S256

8/2/11

135-Day

Frontier, Frontier II and Anthem Families of CRT-Ps St. Jude Medical

Cardiac Rhythm Management

Sylmar, CA

91342

Approval for additional manufacturing screening tests for a device component.
P910023/S264

8/3/11

180-Day

Cadence Family of ICDs St. Jude Medical, Cardiac Rhythm Management

Sylmar, CA

91342

Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P910023/S267

8/17/11

Real-Time

St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices St. Jude Medical Cardiac Rhythm Management

Sunnyvale, CA

94086

Approval for minor modifications to the patient manuals packaged with the devices.
P920047/S045

8/12/11

180-Day

Blazer Prime HTD Cardiac Ablation Catheters Boston Scientific Corporation

San Jose, CA

95134

Approval for a manufacturing site located at Boston Scientific Corporation in Heredia, Costa Rica.
P940019/S025

8/17/11

Real-Time

WALLSTENT® Iliac Endoprosthesis with Unistep™ Plus Delivery System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for labeling changes related to the MR compatibility of the device.
P950022/S077

8/5/11

Real-Time

Connector Sleeve Accessory Kit St. Jude Medical

Sylmar, CA

91342

Approval for a connector sleeve accessory kit Model EX3151. The connector sleeve is indicated for use with IS-4 and DF-4 lead connectors to facilitate the connection to a pacing system analyzer at the time of implant.
P950029/S060

8/18/11

Real-Time

REPLY/ESPRIT SR/DR Pacemaker Sorin CRM USA, Inc.

Plymouth, MN 55441

Approval for the addition of the Dplus and Acceleration and Atrial Ventricular Delay Reduction pacing modes along with minor software updates.
P960009/S125

8/26/11

Special

Soletra, Kinetra, Activa PC, Activa SC and Activa RC INS Medtronic Neuromodulation

Minneapolis, MN 55432

Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition of precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.
P960043/S073

8/24/11

Real-Time

Prostar XL Percutaneous Vascular Surgical System Abbott Vascular, Inc.

Redwood City, CA

94063

Approval for changes to packaging and packaging integrity testing.
P970003/S117

8/26/11

180-Day

VNS Therapy Systems Cyberonics, Inc.

Houston, TX

77058

Approval for a manufacturing site located at Cyberonics in Austin, Texas.
P970004/S108

8/19/11

135-Day

InterStim II Neurostimulator Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for changes to the procedure for confirming that the ultrasonic staking of two washers has been performed and a modification of a tool used to ensure the setscrew is present in the setscrew block.
P970004/S121

8/25/11

180-Day

InterStim II Implantable Neurostimulator Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for a sterilization site located at Sterigenics US, Inc. in Queensbury,

New York .

P970004/S125

8/26/11

Special

Medtronic InterStim® Therapy for Urinary Control Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition or precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.
P970013/S040

8/3/11

180-Day

Microny Family of Pacemakers St. Jude Medical, Cardiac Rhythm Management

Sylmar, CA

91342

Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P970013/S041

8/17/11

Real-Time

St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices St. Jude Medical Cardiac Rhythm Management

Sunnyvale, CA

94086

Approval for minor modifications to the patient manuals packaged with the devices.
P970051/S070

8/30/11

135-Day

Nucleus Cochlear Implant System Cochlear Americas

Centennial, CO

80111

Approval for a change to the diameter specification of the wire used in the electrodes of the cochlear implant system.
P970051/S074

8/30/11

135-Day

Nucleus Cochlear Implant System Cochlear Americas Centennial, CO

80111

Approval for a change to move the inner and outer moulding process of a transformer pod in-house, and modify the shape of the inner-mould.
P970051/S082

8/19/11

135-Day

Nucleus Cochlear Implant System Cochlear Americas Centennial, CO

80111

Approval to add inspection checks.
P980016/S298

8/18/11

180-Day

Medtronic Secura D224DRG/ D224VRC, Maximo II D284DRG/ D284VRC,

Virtuoso II D274DRG/ D274VRC, Protecta XT DR D314DRG, Protecta DR D334DRG, Protecta XT VR D314VRG, Protecta VR D334VRG

Medtronic, Inc.

Mounds View, MN

55112

Approval for design, materials, and manufacturing changes to the hybrids used in the Gen2 and Adams hybrid platforms.
P980022/S067

8/29/11

180-Day

MiniMed Continuous Glucose Monitoring System Medtronic, Inc.

Northridge, CA

91325

Approval for a change in the raw material used in the adhesive patch of the glucose sensor component (models MMT-7002 and MMT-7003) of the device.
P990020/S045

8/18/11

135-Day

Aneurx AAAdvantage Stent Graft with the Xcelerant Hydro Delivery System Medtronic Vascular Santa Rosa, CA

95403

Approval for automation of your inventory management system.
P000008/S023

8/15/11

180-Day

LAP-BAND® Adjustable Gastric Banding System Allergan, Inc.

Goleta, CA

93117

Approval of the post-approval study protocol.
P000010/S019

8/17/11

135-Day

AMPLICOR HCV Test, Version 2.0 Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Approval for changes made to the acceptance criteria for a conjugate bulk solution used in the device.
P000025/S051

8/26/11

135-Day

COMBI 40+ Cochlear Implant System MED-EL Corporation

Durham, NC

27713

Approval for: 1) new calibration process for vacuum oven; 2) changes to transfer presses and parameters for the closing force; 3) release of new equipment used for the magnet-peel test; 4) release of new insert equipment; 5) merged 2 production systems; 6) change to a lead free solder, and glue of the microphone; 7) release of a new fixture “RTV Stander”; 8) change of battery pack test box; 9) new coating equipment and clamping device; and 10) qualification for new grinding and polishing equipment and equipment used for the vacuum impregnation of micrographs.
P000057/S006

8/26/11

135-Day

Ascension MCP Ascension Orthopedics, Inc. Austin, TX

78754

Approval for a change to the coating supplier manufacturing facility.
P010012/S260

8/5/11

135-Day

Acuity Spiral Lead Family Boston Scientific Corporation

St. Paul, MN

55112

Approval for the following changes:

1) add an alternate Dexamethasone Acetate supplier;

2) update to DXA mixing process parameters to enhance process capability;

3) alternate analytical method to test for dosage and product degradation;

4) modification of the analytical methods to remove impurity peaks observed; and

5) add in process verification for mix homogeneity.

P010012/S268

8/5/11

Real-Time

EASYTRAK 2 Boston Scientific Corporation

St. Paul, MN

55112

Approval for changes to the polyurethane tubing specifications and the addition of an alternate polyurethane tubing supplier.
P010014/S014

8/5/11

180-Day

Oxford® Unicompartmental Knee System Biomet Manufacturing Corporation

Warsaw, IN

46582

Approval for manufacturing sites located at Biomet Orthopedics, Inc. in Warsaw, Indiana and Steris, Inc. in Libertyville, Illinois.
P010021/S019

8/2/11

135-Day

Vitros Immunodiagnostic Products Anti-HCV Reagent Pack & Calibrator Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Approval for the replacement of a raw material, foetal calf serum, with bovine serum albumin in the formulation of the VITROS Anti-HCV conjugate reagent.
P010030/S029

8/3/11

Real-Time

LifeVest Wearable Defibrillators ZOLL Lifecor Corporation

Pittsburgh, PA

15238

Approval for several minor hardware updates to lead-free alternate components for the devices.
P010031/S252

8/18/11

180-Day

Medtronic Consulta D224TRK, Maximo II D284TRK, Concerto II D274TRK,

Protecta XT CRT-D D314TRG, Protecta CRT-D D334TRG

Medtronic, Inc.

Mounds View, MN

55112

Approval for design, materials, and manufacturing changes to the hybrids used in the Gen2 and Adams hybrid platforms.
P010032/S040

8/12/11

Special

EON C IPG (Implantable Pulse Generator System) St. Jude Medical

Plano, TX

75024

Approval for labeling changes to include additional information regarding battery passivation in the EON C IPG Directions for Use.
P020025/S026

8/12/11

180-Day

Blazer Prime XP Cardiac Ablation Catheters Boston Scientific Corporation

San Jose, CA

95134

Approval for a manufacturing site located at Boston Scientific Corporation in Heredia, Costa Rica.
P030002/S020

8/5/11

180-Day

Crystalens® Accommodating Intraocular Lens Bausch & Lomb, Inc.

Aliso Viejo, CA

92656

Approval to market Crystalens® Model AT-45 Accommodating Intraocular

Lens (IOL) with a Benzotriazole ultra-violet (UV) absorber chromophore (UVAM), to be

designated as Models AT1UV, AT2UV, HD1UV, HD2UV, AO1UV and AO2UV.

P030035/S078

8/2/11

135-Day

Cadence, Current and Fortify Families of ICDs St. Jude Medical

Cardiac Rhythm Management

Sylmar, CA

91342

Approval for additional manufacturing screening tests for a device component.
P030035/S083

8/3/11

180-Day

Frontier, Frontier II and Anthem Family of CRT-Ps St. Jude Medical, Cardiac Rhythm Management

Sylmar, CA

91342

Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P030035/S086

8/17/11

Real-Time

St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices St. Jude Medical Cardiac Rhythm Management

Sunnyvale, CA

94086

Approval for minor modifications to the patient manuals packaged with the devices.
P030042/S004

8/8/11

Real-Time

CONSERVE® Plus Total Resurfacing Hip System Wright Medical Technology, Incorporated

Arlington, TN

38002

Approval for the CONSERVE Plus A-Class Femoral Component and the CONSERVE Plus Thick Acetabular Shell to be used as components of the device.
P030054/S180

8/2/11

135-Day

Epic HF, Atlas+ HF, Promote and Unity Families of CRT-Ds St. Jude Medical

Cardiac Rhythm Management

Sylmar, CA

91342

Approval for additional manufacturing screening tests for a device component.
P030054/S189

8/3/11

180-Day

Epic HF and Atlas+ HF Family of

CRT-Ds

St. Jude Medical, Cardiac Rhythm Management

Sylmar, CA

91342

Approval for Model 3330 Programmer Software version 10.1.2, which includes minor modifications to the pacing lead impedance feature.
P030054/S192

8/5/11

Real-Time

Connector Sleeve Accessory Kit St. Jude Medical

Sylmar, CA

91342

Approval for a connector sleeve accessory kit Model EX3151. The connector sleeve is indicated for use with IS-4 and DF-4 lead connectors to facilitate the connection to a pacing system analyzer at the time of implant.
P030054/S193

8/17/11

Real-Time

St. Jude Medical ICD, Pacemaker, CRT-P and CRT-D Devices St. Jude Medical Cardiac Rhythm Management

Sunnyvale, CA

94086

Approval for minor modifications to the patient manuals packaged with the devices.
P040003/S009

8/9/11

180-Day

ExAblate 2000/2100 1.5 and 3T Magnetic Resonance Guided Focused Ultrasound InSightec, Ltd.

Dallas, TX

75244

Approval for updated labeling including long-term data from the post-approval study.
P040043/S039

8/23/11

180-Day

GORE TAG Thoracic Endoprosthesis W.L Gore & Associates, Inc.

Flagstaff, AZ

86001

Approval for a modified version of the TAG Thoracic Endoprosthesis. The TAG Device is indicated for endovascular repair of aneurysms of the descending thoracic aorta in patients who have appropriate anatomy, including adequate iliac/ femoral access, aortic inner

diameter in the range of 16-42 mm, and ≥ 20 mm non-aneurysmal aorta proximal and distal to the aneurysm.

P050037/S029

8/2/11

Real-Time

Radiesse® Injectable Implant Merz Aesthetics, Inc.

Franksville, WI

53126

Approval for the addition of a number of precautions to the Instructions for Use.
P050052/S032

8/2/11

Real-Time

Radiesse® Injectable Implant Merz Aesthetics, Inc.

Franksville, WI

53126

Approval for the addition of a number of precautions to the Instructions for Use.
P060008/S067

8/12/11

180-Day

TAXUS Liberté Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for revised labeling to include updated clinical trial data through the final 5-year time point for the TAXUS ATLAS study and through three (3) years for the TAXUS ATLAS Small Vessel and Long Lesion studies.
P070007/S029

8/18/11

135-Day

Talent Thoracic Stent Graft with the Xcelerant and Captivia Delivery System Medtronic Vascular Santa Rosa, CA

95403

Approval for automation of your inventory management system.
P070015/S064

8/23/11

135-Day

XIENCE V and Promus Everolimus Eluting Coronary Stent systems (EECSS) Abbott Vascular

Temecula, CA

92591

Approval for the transfer of several everolimus drug tests from a third party lab to the Abbott Vascular Technical Service Lab in Temecula, California.
P070022/S020

8/9/11

Real-Time

Adiana Permanent Contraception System Hologic, Inc.

Marlborough, MA

01752

Approval for a change of the acceptance criteria for the deployment force exerted on a polyurethane ring in the Adiana catheter.
P070027/S029

8/18/11

135-Day

Talent Abdominal Stent Graft with the Xcelerant Hydro Delivery System Medtronic Vascular Santa Rosa, CA

95403

Approval for automation of your inventory management system.
P080013/S007

8/18/11

Special

DuraSeal™ Exact Spine Sealant System Covidien

Bedford, MA

01730

Approval for a modification to the instructions for use to instruct the surgeon in the best practices in applying the sealant.
P080025/S013

8/25/11

180-Day

InterStim II Implantable Neurostimulator Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for a sterilization site located at Sterigenics US, Inc. in Queensbury,

New York .

P080025/S018

8/26/11

Special

Medtronic InterStim® Therapy System Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for labeling changes to the manual for the Model 8840 N’Vision Clinician Programmer. These changes include the addition or precautions related to modification of the device, the effect of electromagnetic interference (EMI) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other Medtronic labeling for external programming devices.
P100010/S001

8/23/11

180-Day

The Arctic Front Cryocatheter System Medtronic CryoCath

Pointe Claire, Quebec, Canada

H9R 5Z8

Approval of the post-approval study protocol.
P100018/S003

8/30/11

Special

Pipeline™ Embolization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

Irvine, CA

92618

Approval for adding a warning about allergies to metals used in the device and clarifying your instructions for use.
P100021/S004

8/18/11

135-Day

Endurant Stent Graft System Medtronic Vascular Santa Rosa, CA

95403

Approval for automation of your inventory management 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/S030

8/25/11

Hancock I Low Porosity and Modified Orifice Valved Conduit Medtronic, Inc.

Santa Ana, CA

92705

Addition of a glutaraldehyde supplier.
P810031/S040

8/31/11

Sodium Hyaluronate Opthalmic Viscoelastic Devices (OVD) Abbott Medical Optics, Inc.

Santa Ana, CA

92705

Implementation of a new Pure Steam Generator.
P820003/S109

8/4/11

Adaptor: EPG Safety Cable, Disposable Cover Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P820003/S110

8/15/11

Adaptor: EPG Safety Cable, Disposable EPG Cover Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P830061/S070

8/4/11

Capsure, Vitatron Crystaline, Vitatron Excellence +, Vitatron Excellence PS+ Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P830061/S071

8/15/11

Capsure,

Vitatron Crystaline, Vitatron Excellence +, Vitatron Excellence PS+

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P840001/S192

8/5/11

Pisces Lead, Pisces Compact Lead, Pisces Plus Lead, 1x8 Subcompact Lead 3776, 1x8 Standard Lead 3777, 1x8 Compact Lead 3778, 1x8 Subcompact Lead 3876, 1x8 Standard Lead 3877, 1x8 Compact Lead 3878, Hinged 2x4 Surgical Lead, Low Profile Quadripolar Extension, 1x8 Extension, Dual Quadripolar Extension Kit, Single Quadripolar Extension Kit, Specify Surgical Lead, Specify 2x8 Surgical Lead, Specify 5-6-5 Surgical Lead Medtronic, Inc. Minneapolis, MN 55432 Changes to the blister sealing operation and the inspection specifications for that operation.
P840001/S193

8/17/11

Restore Family of Implantable Neurostimulators, Itrel 3 Implantable Neurostimulator Medtronic, Inc.

Minneapolis, MN

55432

Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.
P840001/S194

8/17/11

Restore Family of Implantable Neurostimulators/ Itrel/Synergy/Family of INS/SymMix Surgical Lead Medtronic Neuromodulation

Minneapolis, MN

55432

Update the software used at several of Medtronic’s manufacturing facilities.
P850051/S077

8/4/11

Vitatron Legacy Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P850089/S082

8/4/11

CapSure, CapSure SP Lead, CapSure Z Novus, Vitatron Excellence S+,

Vitatron Excellence SS+, Vitatron Impulse, Vitatron Impulse II

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P850089/S083

8/15/11

CapSure, CapSure Z Novus, Vitatron Excellence S+, Vitatron Excellence SS+, Vitatron Impulse, Vitatron Impulse II Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P860003/S060

8/5/11

THERAKOS CELLEX Photopheresis System THERAKOS, Inc.

Raritan, NJ

08869

Change in supplier for a component.
P860004/S155

8/17/11

Synchromed II Implantable Infusion Pumps Medtronic, Inc.

Minneapolis, MN

55432

Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.
P860004/S156

8/17/11

SynchroMed II Implantable Infusion Pump/Intra-arterial Vascular Catheters/ Vascular Catheters/ InDura 1P Intrathecal Catheters/Intrathecal Catheter Medtronic Neuromodulation

Minneapolis, MN

55432

Update the software used at several of Medtronic’s manufacturing facilities.
P880047/S017

8/18/11

GYNECARE INTERCEED Absorbable Adhesion Barrier Ethicon, Inc.

Somerville, NJ

08876

Addition of a new band sealer.
P890003/S232

8/4/11

Prodigy, Thera I IPG Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P890003/S233

8/4/11

CapSure, CapSure Model, ECG Cable, Prodigy, Service Kit-Pacemaker

Repair Kit

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P890003/S234

8/15/11

CapSure, CapSure Model, ECG Cable, Prodigy, Service Kit-Pacemaker Repair Kit Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P900056/S108

8/25/11

Rotablator Rotational Atherectomy System Boston Scientific Corporation

Maple Grove, MN

55311

Modification and rearrangement of the manufacturing process for efficiency.
P900061/S106

8/4/11

ACE, ACE Header Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P900061/S107

8/4/11

Accessory (upsizing sleeve), Accessory (upsizing sleeve) for unipolar, ACE, ACE 5434T, ACE header, Defibrillation Support Device, Lead End Pin Cap, Oval Patch Lead Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P900061/S108

8/15/11

Accessory (upsizing sleeve), Accessory (upsizing sleeve) for unipolar, ACE, ACE 5434T, ACE header, Defibrillation Support Device, Lead End Pin Cap, Oval Patch Lead Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P910023/S268

8/12/11

Fortify DR and Fortify VR ICDs St. Jude Medical

Sylmar, CA

91342

Change in Automated Manufacturing Tests (ATE) used at the half-can level.
P910023/S269

8/15/11

Cadence Family of ICDs St. Jude Medical

Sylmar, CA

91342

Addition of secondary suppliers for the thyristor SCR and the High Voltage/Current diode components.
P920015/S081

8/4/11

"Y" Adaptor/ Extender Kit, DF-1 Connector Port Pin Plug, IS-1 Connector

Port Pin Plug Kit, Lead Adaptor, Sprint,

Sprint Quattro, Sprint Quattro

Lead, SUBCUTANEOUS LEAD, Transvene SVC Lead, Tunneling Tool

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P920015/S082

8/15/11

"Y" Adaptor/ Extender Kit, DF-1 Connector Port

Pin Plug, IS-1 Connector

Port Pin Plug Kit, Lead Adaptor, Sprint,

Sprint Quattro, Sprint Quattro

Lead, SUBCUTANEOUS LEAD, Sub-Q Defibrillation Lead, Transvene SVC Lead, Tunneling Tool

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P930029/S032

8/4/11

Cable ATAKR to ECG, Conductr 5 Mm 8fr, Conductr RF MC 0786022,

Contactr Catheter 7 Fr 5 Mm (70257533), Contatr Catheter 7 Fr 5 Mm

(70256034), RF Conductr MC Self-Reference Catheter, RF Enhancr II

Ablation catheter, RF MARIN UNI 112 CM 6L, RF Marinr MC 7F 5/5/5, RF Marinr MC 7fr 112 Cm, RF Marinr MC 7fr 2-5-2, RF MARINR MC

UN 110CM, RF Marinr MCXL 5/5/5, RF Marinr MC, XI 7fr, RF Marinr

SC 5F 80CM, RF Marinr Sc XI 5fr 110cm, RF Marinr Sc Xs 5fr 110cm,

RF Marinr SCXL 5F 80CM, RF MarinrSCXXL 5F 80CM

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P930029/S033

8/15/11

RF Conductr MC, RF Contactr,

RF Enhancer II,

RF Marinr MC 7f/SC 5f,

RF Marinr Unipolar, RF Conductr MC Ablation Catheters

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P930031/S030

8/4/11

WALLSTENT™ (TIPS) Endoprosthesis Boston Scientific Corporation

Maple Grove, MN

55311

Alternate vendor for the distal tip component of the delivery system for the devices.
P930039/S060

8/4/11

CapSure, SureFix, Torque Clip - accessory for 5076 lead, Vitatron Crystalline ActFix, Vitatron Pirouet S+ Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P930039/S061

8/15/11

CapSure, SureFix, Torque Clip - accessory for 5076 lead, Vitatron Crystalline ActFix, Vitatron Pirouet S+ Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P940019/S026

8/4/11

WALLSTENT™ (Iliac) Endoprosthesis Boston Scientific Corporation

Maple Grove, MN

55311

Alternate vendor for the distal tip component of the delivery system for the devices.
P950020/S046

8/4/11

Flextome Cutting Balloon and Cutting Balloon Ultra 2 Boston Scientific Corporation

Maple Grove, MN

55311

Change to the inflation manifold component inspection process.
P950024/S034

8/4/11

CapSure Epicardial Pacing Lead Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P950024/S035

8/15/11

CapSure Epicardial Pacing Lead Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P950029/S061

8/29/11

Reply/Esprit IPG ELA Medical, Inc.

Plymouth, MN

55441

Change to the reflow soldering profile and an alternate tooling used for the passing oven.
P960009/S122

8/5/11

DBS Lead, DBS Lead - Reduced Spacing Extension, DBS Extension Medtronic, Inc. Minneapolis, MN 55432 Changes to the blister sealing operation and the inspection specifications for that operation.
P960009/S123

8/17/11

Activa Family of Implantable Neurostimulators, Soletra Implantable Neurostimulator, Kinetra Implantable Neurostimulator Medtronic, Inc.

Minneapolis, MN

55432

Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.
P960009/S124

8/17/11

Activa Family of INS/Soletra INS/ Kinetra INS Medtronic Neuromodulation

Minneapolis, MN

55432

Update the software used at several of Medtronic’s manufacturing facilities.
P960016/S037

8/4/11

Livewire TC™ Cardiac Ablation System St. Jude Medical Minnetonka, MN 55345 Update the UV Trimming process.
P960043/S074

8/10/11

Suture Medicated Closure Systems, Percutaneous Vascular Surgical Systems and Associated Accessories Abbott Vascular, Inc.

Redwood City, CA

94063

Change in BET location and technique.
P970003/S131

8/11/11

VNS Therapy® System Cyberonics, Inc.

Houston, TX

77058

Change to modify the electrical test system software.
P970003/S132

8/4/11

VNS Therapy® System Pulse Generators Cyberonics, Inc.

Houston, TX

77058

Use of a new piece of equipment for a quality systems test.
P970003/S133

8/31/11

VNS Therapy®

Therapy System

Cyberonics, Inc.

Houston, TX

77058

Change to add additional testing for the flash memory cards.
P970004/S120

8/5/11

Leads 3080/3886/3889/ 3093, Lead Extension 3095 Medtronic, Inc. Minneapolis, MN 55432 Changes to the blister sealing operation and the inspection specifications for that operation.
P970004/S122

8/17/11

Interstim Family of Implantable Neurostimulators Medtronic, Inc.

Minneapolis, MN

55432

Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.
P970004/S123

8/17/11

InterStim Family of INS Medtronic Neuromodulation

Minneapolis, MN

55432

Update the software used at several of Medtronic’s manufacturing facilities.
D970012/S087

8/25/11

AMS Ambicor Penile Prosthesis American Medical Systems

Minnetonka, MN

55343

Replacement mold insert.
P970012/S088

8/4/11

Kappa 400 IPG Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P970020/S066

8/10/11

MultiLink Zeta Coronary Stent System Abbott Vascular

Temecula, CA

92591

Change to a component in-process inspection.
P970031/S034

8/25/11

Freestyle Aortic Root Bioprosthesis Medtronic, Inc.

Santa Ana, CA

92705

Addition of a glutaraldehyde supplier.
P970055/S011

8/3/11

Biotrin International’s Parvovirus B19 IgM Enzyme Immunoassay Biotrin International Ltd.

Dublin, Ireland

Manufacturing process change for preparation of the Sensitivity Standards, used as a reference material to establish the cut-off value for the device.
P980016/S310

8/4/11

EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso II ICDs Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P980016/S311

8/4/11

Capsure, EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso II Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P980016/S312

8/11/11

Maximo II/Secura/ Virtuoso Medtronic, Inc.

Mounds View, MN

55112

Changes to the final functional test application.
P980016/S313

8/12/11

Maximo II, Protecta, Protecta XT Secura, Virtuoso II ICDs Medtronic, Inc.

Mounds View, MN

55112

Manufacturing site change of supplier and a minor change to the wire drawing process.
P980016/S315

8/15/11

EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso II Medtronic, Inc.

Mounds View, MN

55112

Changes to a manufacturing aid.
P980016/S316

8/15/11

CapSure, EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso II Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P980016/S317

8/19/11

Maximo II, Protecta, Protecta XT, Secura, Virtuoso II CRT’s Medtronic, Inc.

Mounds View, MN

55112

Change the Butted Contact (BTC) etch time.
P980016/S318

8/18/11

Protecta (D334DRG, D334VRG) and Protecta XT (D314DRG, D314VRG) Medtronic, Inc.

Mounds View, MN

55112

Changes to the radio frequency testing of hybrids.
P980033/S019

8/4/11

WALLSTENT™ (Venous) Endoprosthesis Boston Scientific Corporation

Maple Grove, MN

55311

Alternate vendor for the distal tip component of the delivery system for the devices.
P980035/S235

8/4/11

350 Series, Adapta, Advisa, EnRhythm, AT500, Relia, Sensia, Sigma, EnPulse, Versa IPGs Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P980035/S236

8/4/11

350 Series, Adapta, Advisa, EnRhythm, Relia, Sensia, Sigma Versa Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P980035/S237

8/15/11

Advisa, AT500, EnRhythm Medtronic, Inc.

Mounds View, MN

55112

Changes to a manufacturing aid.
P980035/S238

8/15/11

350 Series, Adapta, Advisa, EnRhythm, Relia, Sensia, Sigma, Versa Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P980035/S239

8/19/11

EnRhythm Implantable Pulse Generator Medtronic, Inc.

Mounds View, MN

55112

Change the Butted Contact (BTC) etch time.
P980043/S032

8/25/11

Hancock II Porcine Bioprosthesis Medtronic, Inc.

Santa Ana, CA

92705

Addition of a glutaraldehyde supplier.
P980046/S008

8/31/11

Home Access® Hepatitis C Check SM Test System Home Access Health Corporation

Hoffman Estates, IL

60169

New supplier for the barrier pouch component of the device.
P980050/S065

8/4/11

Transvene CS/SVC Lead (w/polyurethane sheath) Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P980050/S066

8/15/11

Transvene CS/SVC Lead (w/polyurethane sheath) Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P990001/S092

8/4/11

Vitatron DA+

C-Series, Vitatron DA+ T-Series, Vita IPGs

Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P990001/S093

8/4/11

Vitatron DA+ C-Series, Vitatron DA+ T-Series Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P990001/S094

8/15/11

Vitatron DA+

C-Series, Vitatron DA+ T-Series

Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P990034/S024

8/17/11

Side Catheter Access Ports Kits/ Bulk/Refill Kits/Bulk Medtronic Neuromodulation

Minneapolis, MN

55432

Update the software used at several of Medtronic’s manufacturing facilities.
P990064/S039

8/25/11

Mosaic Porcine Bioprosthesis Medtronic, Inc.

Santa Ana, CA

92705

Addition of a glutaraldehyde supplier.
P000006/S025

8/18/11

Titan Inflatable Penile Prosthesis Coloplast Corporation

Minneapolis, MN 55411

Addition of another supplier of tubing.
P000010/S023

8/9/11

AMPLICOR® HCV Test, Version 2 Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Change to the manufacturing batch size for the Bulk Specimen Diluent, which is a component of the device.
P000012/S032

8/9/11

COBAS AMPLICOR HCV Test, v2.0 Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Change to the manufacturing batch size for the Bulk Specimen Diluent, which is a component of the device.
P010013/S039

8/18/11

NovaSure Impedance Controlled Endometrial Ablation System Hologic, Inc.

Marlborough, MA

01752

Implementation of a new de-knitting machine.
P010015/S132

8/4/11

Consulta CRT-P, InSync III CRT-P, Syncra CRT-P Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P010015/S134

8/4/11

Attain, Consulta CRT-P, InSync III, Syncra CRT-P Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P010015/S135

8/15/11

Consulta, CRT-P, InSync, InSync III, Syncra CRT-P Medtronic, Inc.

Mounds View, MN

55112

Changes to a manufacturing aid.
P0100015/S136

8/15/11

Attain, Consulta CRT-P, InSync III, Syncra CRT-P Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P010015/S137

8/19/11

Consulta CRT-P, Syncra CRT-P Medtronic, Inc.

Mounds View, MN

55112

Change the Butted Contact (BTC) etch time.
P010031/S264

8/4/11

Concerto, Concerto II CRT-D,

Consulta CRT-D, InSync II Marquis, InSync III Marquis, InSync Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta XT CRT-Ds

Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P010031/S265

8/4/11

Concerto,

Concerto II, Consulta,

InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta II

Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P010031/S266

8/11/11

Concerto II/ Consulta/Maximo II Medtronic, Inc.

Mounds View, MN

55112

Changes to the final functional test application.
P010031/S267

8/12/11

Concerto II, Consulta, Maximo II, Protecta, Protecta II CRTs Medtronic, Inc.

Mounds View, MN

55112

Manufacturing site change of a supplier and a minor change to the wire drawing process.
P010031/S269

8/15/11

Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta XT Medtronic, Inc.

Mounds View, MN

55112

Changes to a manufacturing aid.
P010031/S270

8/15/11

Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta XT Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P010031/S271

8/19/11

Concerto II, Consulta, Maximo II, Protecta, Protecta XT CRT’s Medtronic, Inc.

Mounds View, MN

55112

Change the Butted Contact (BTC) etch time.
P010031/S272

8/18/11

Protecta (D334TRG) and Protecta XT (D314TRG) Medtronic, Inc.

Mounds View, MN

55112

Changes to the radio frequency testing of hybrids.
P010033/S018

8/23/11

QuantiFERON® - TB Gold Cellestis, Inc.

Valencia, CA

91355

Change of a vendor for Glucose testing from Australia to USA.
P010054/S015

8/8/11

Elecsys Anti-HBs Immunoassay Roche Diagnostics Corporation

Indianapolis, IN

46250

Change the in-process method to determine the particle concentration of the Elecsys coated microparticles (beads).
P020001/S008

8/4/11

STAN S31 Fetal Heart Monitor Neoventa Medical AB

Alexandria, VA 22314

Addition of an inspection test for the device.
P020025/S030

8/18/11

Maestro 3000 Cardiac Ablation System Boston Scientific Corporation

San Jose, CA

95134

Eight (8) test application changes to the Final Functional Test Release.
P020047/S037

8/10/11

Vision and Mini-Vision Coronary Stent System Abbott Vascular

Temecula, CA

92591

Change to a component in-process inspection.
P030022/S019

8/12/11

Reflection Ceramic Hip System (RCHS) Smith & Nephew, Inc.

Memphis, TN

38116

Changes to the specification governing the requalification of the ETO sterilization process for the device.
P030036/S035

8/4/11

Anchoring Sleeve Kit, SelectSecure Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P030036/S036

8/15/11

Anchoring Sleeve Kit, SelectSecure Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P030054/S194

8/12/11

Unify CRT-D St. Jude Medical

Sylmar, CA

91342

Change in Automated Manufacturing Tests (ATE) used at the half-can level.
P030054/S195

8/15/11

Epic HF/Atlas+ HF Family of CRT-Ds St. Jude Medical

Sylmar, CA

91342

Addition of secondary suppliers for the thyristor SCR and the High Voltage/Current diode components.
P040016/S075

8/4/11

Liberté Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Change to the inflation manifold component inspection process.
P040024/S054

8/18/11

Restylane Injectable Gel Medicis Pharmaceutical Corporation

Scottsdale, AZ

85256

New fill volume for the device and a new needle size to be used with the new fill volume.
P050007/S029

8/10/11

Vascular Closure Systems Abbott Vascular, Inc.

Redwood City, CA

94063

Change in BET location and technique.
P050012/S038

8/12/11

Dexcom SEVEN® and SEVEN® PLUS Continuous Glucose Monitoring Systems Dexcom, Inc.

San Diego, CA

92121

Removal of redundant deburring steps from the cleaning processes of the needle and cannula components of the SEVEN and SEVEN PLUS Continuous Glucose Monitoring Systems.
P060008/S074

8/4/11

TAXUS Liberté Long Paclitaxel- Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Change to the inflation manifold component inspection process.
P060039/S029

8/4/11

Attain StarFix Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P060039/S030

8/15/11

Attain StarFix Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P070001/S011

8/18/11

ProDisc-C Total Disc Replacement Synthes Spine

West Chester, PA

19380

Change to the location of the tray manufacturing and raw material supplier.
P070015/S076

8/10/11

XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System (EECSS) Abbott Vascular

Temecula, CA

92591

Change to a component in-process inspection.
P070015/S078

8/25/11

XIENCE nano and PROMUS Everolimus Eluting Coronary Stent Systems Abbott Vascular

Temecula, CA

92591

Changes to include: 1) removal of initial clean and plasma treatment; 2) removal of drug final weigh; 3) modified clean room gowning; and 3) modifications to the spray coating process.
P080006/S033

8/4/11

Attain Ability, Attain Ability Plus, Attain Ability Straight Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P080006/S034

8/15/11

Attain Ability, Attain Ability Plus, Attain Ability Straight Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P080014/S009

8/2/11

Cervista® HPV HR Hologic, Inc.

Marlborough, MA

01752

Change in the statistical method employed during incoming material inspection of the HPV Controls of the Cervista® HPV HR and reagents in the Genfind® DNA Extraction Kit.
P080015/S005

8/2/11

Cervista® HPV 16/18 Hologic, Inc.

Marlborough, MA

01752

Change in the statistical method employed during incoming material inspection of the HPV Controls of the Cervista® HPV 16/18 and reagents in the Genfind® DNA Extraction Kit.
P080025/S012

8/5/11

Leads 3889/3093, Lead Extension 3095 Medtronic, Inc.

Minneapolis, MN

55432

Changes to the blister sealing operation and the inspection specifications for that operation.
P080025/S014

8/17/11

Interstim Family of Implantable Neurostimulators Medtronic, Inc.

Minneapolis, MN

55432

Implement a change in a manufacturing aid material, as well as a change in component specification and inspection process at a component supplier.
P080025/S015

8/17/11

InterStim Family of INS Medtronic Neuromodulation

Minneapolis, MN

55432

Update the software used at several of Medtronic’s manufacturing facilities.
P080025/S017

8/24/11

InterStim II Neurostimulator Medtronic Neuromodulation

Minneapolis, MN

55432

Changes to manufacturing equipment and in process inspectional methods.
P080025/S019

8/30/11

InterStim II Neurostimulator Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of a new manufacturing mold and a new component supplier.
P090013/S031

8/4/11

Revo MRI IPG Medtronic, Inc.

Mounds View, MN

55112

Manufacturing process change for the determination of worst case device representative for ethylene oxide (EO) residual testing for ethylene oxide sterilization.
P090013/S032

8/4/11

CapSure Fix Lead, Revo MRI Medtronic, Inc.

Mounds View, MN

55112

Software upgrade for the manufacturing execution system.
P090013/S033

8/15/11

Revo MRI Medtronic, Inc.

Mounds View, MN

55112

Changes to a manufacturing aid.
P090013/S034

8/15/11

CapSure Fix Lead, Revo MRI Medtronic, Inc.

Mounds View, MN

55112

Modification to equipment calibration control.
P090013/S035

8/19/11

Revo MRI Medtronic, Inc.

Mounds View, MN

55112

Change the Butted Contact (BTC) etch time.
P090022/S006

8/25/11

Softec HD, Softec I, and Softec HD PS Intraocular Lenses Lenstec, Inc.

Saint Petersburg, FL

33716

Use of an alternative supplier of the silicone vial stopper.
P100013/S001

8/25/11

EXOSEAL™ Vascular Closure Device Cordis Corporation

Bridgewater, NJ

08807

Change in the processing of a component of the device.
P100014/S002

8/10/11

Solesta Injectable Gel Schiff & Company

West Caldwell, NJ 07006

Relocation of the Quality Control Laboratory to a new location within Q-Med AB’s existing facility.
P100021/S009

8/10/11

Endurant Stent Graft System Medtronic Vascular

Santa Rosa, CA

95403

Several manufacturing changes at the component supplier.
P100023/S009

8/4/11

ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Manufacturing process step to enhance scanning and data retrieval function.
P100023/S011

8/4/11

ION Paclitaxel-Eluting Coronary Stent System Monorail Boston Scientific Corporation

Maple Grove, MN

55311

Change to the inflation manifold component inspection process.
P100023/S012

8/4/11

ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Optimization of in-process manufacturing inspections.
P100023/S014

8/11/11

ION (Taxus Element) Paclitaxel-Eluting Stent Boston Scientific Ireland, Inc.

Maple Grove, MN

55311

Modification of the sleeve cutting guide fixture.

Summary of PMA Originals & Supplements Approved

Originals: 3

Supplements: 70

Summary of PMA Originals Under Review

Total Under Review: 92

Total Active: 47

Total On Hold: 45

Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review

Total Under Review: 619

Total Active: 433

Total On Hold:186

Number Greater Than 180 Days: 11

Summary of All PMA Submissions Received

Originals: 2

Supplements: 69

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 70

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 157.2

FDA Time: 105.4 Days MFR Time: 51.8 Days

SOURCE

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