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PMA Final Decisions for July 2010

Mon, 08/23/2010 - 1:38pm
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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N18033/S047

7/22/10

VISTAKON® (etafilcon A) Contact Lenses, Clear and Visibility Tinted with UV BlockerJohnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Alternate method for visual inspection of raw materials.
P790007/S026

7/28/10

Hancock® I Low Porosity and Modified Orifice Valved ConduitMedtronic, Inc.

Santa Ana, CA

92705

Addition of a component manufacturer.
P790017/S108

7/1/10

Gruntzig Dilaca Balloon Dilatation CathetersMedtronic Vascular

Santa Rosa, CA

95403

Change to introduce the MicroVu measurement system for the dimensional measurements of extruded tubing.
P840001/S156

7/20/10

Restore Family of Implantable NeurostimulatorsMedtronic Neuromodulation

Minneapolis, MN

55432

Changes to the traceability software.
P840001/S157

7/29/10

Restor Implantable NeurostimulatorsMedtronic Neuromodulation

Minneapolis, MN

55432

Addition of an alternate supplier for the gold plating process.
P860004/S134

7/20/10

Synchromed II Implantable Infusion PumpsMedtronic Neuromodulation

Minneapolis, MN

55432

Changes to the traceability software.
P860004/S135

7/29/10

Pump, Infusion, Implanted, ProgrammableMedtronic Neuromodulation

Minneapolis, MN

55432

Addition of an alternate supplier for the gold plating process.
P860019/S258

7/28/10

Boston Scientific Corporation® Apex™ Monorail™ and Over-the-Wire PTA Dilatation CathetersBoston Scientific Cardiovascular

Maple Grove, MN

55311

Update of software used with a camera for inspecting the inner component at the Apex Distal Load manufacturing process.
P860057/S069

7/9/10

Carpentier-Edwards® Perimount® Pericardial BioprosthesesEdwards Lifesciences, LLC

Irvine, CA

92614

Addition of a new supplier for bovine pericardial tissue.
P870076/S011

7/8/10

Falope-Rings® Band and Applicator SystemsGyrus ACMI, Inc.

Southborough, MA

01772

Change in supplier of three components of the device.
P870078/S010

7/28/10

Hancock® Porcine BioprosthesisMedtronic, Inc.

Santa Ana, CA

92705

Addition of a component manufacturer.
P880086/S190

7/15/10

Affinity/Integrity/ Victory Family of PacemakersSt. Jude Medical, Inc.

Sylmar, CA

91342

Addition of alternate suppliers for discrete components used on St. Jude Medical’s devices.
P880086/S191

7/16/10

Verity, Identity, Victory, and Zephyr Families of Implantable PacemakersSt. Jude Medical, Inc.

Sylmar, CA

91342

Change to the resistance weld process electrode.
P900061/S090

7/23/10

Transvene Defibrillation LeadMedtronic, Inc.

Mounds View, MN

55112

Changes at the final package assembly.
P910023/S237

7/15/10

Cadence Family of ICDsSt. Jude Medical, Inc.

Sylmar, CA

91342

Addition of alternate suppliers for discrete components used on St. Jude Medical’s devices.
P910077/S105

7/22/10

Latitude™ Inductive Communicator and Latitude™ RF CommunicatorBoston Scientific Corporation

St. Paul, MN

55112

Change in the bond line thickness and lead frame plating for the digital potentiometer.
P930038/S062

7/15/10

Angio-Seal™ Vascular Closure DeviceSt. Jude Medical Cardiovascular Division

St. Paul, MN

55128

Alternate seal strength specification assurance method.
P950022/S071

7/15/10

Durata Family of LeadsSt. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Change in the medical Adhesive cleaning process.
P960009/S087

7/20/10

Activa Family of Implantable NeurostimulatorsMedtronic Neuromodulation

Minneapolis, MN

55432

Changes to the traceability software.
P960009/S088

7/29/10

Stimulator, Implanted, for ParkinsonsMedtronic Neuromodulation

Minneapolis, MN

55432

Addition of an alternate supplier for the gold plating process.
P960042/S017

7/15/10

SLS II Laser SheathSpectranetics Corporation

Colorado Springs, CO

80921

Change to the vacuum oven.
P970004/S088

7/14/10

InterStim II® NeurostimulatorMedtronic Neuromodulation

Minneapolis, MN

55432

Change to the test specification limits of an existing manufacturing test related to the final functional test.
P970004/S089

7/20/10

Interstim Family of Implantable NeurostimulatorsMedtronic Neuromodulation

Minneapolis, MN

55432

Changes to the traceability software.
P970004/S090

7/29/10

Restor Implantable NeurostimulatorsMedtronic Neuromodulation

Minneapolis, MN

55432

Addition of an alternate supplier for the gold plating process.
P970008/S051

7/16/10

Urologix Targis® System for the Treatment of BPHUrologix, Inc.

Minneapolis, MN

55447

Change in the supplier of solder used in the manufacture of the Targis Short Catheter.
P970012/S070

7/23/10

Kappa 400 IPGMedtronic, Inc.

Mounds View, MN

55112

Addition of a new piece of equipment used in the battery burn-in process.
P970020/S056

7/20/10

Multi-Link OTW ZETA® Coronary Stent System and Multi-Link RX ZETA® Coronary Stent SystemAbbott Vascular, Inc.

Temecula, CA

92591

Increase in the minimum seal length requirement for the manufacturing of the stent delivery system.
P980016/S245

7/7/10

EnTrust, Virtuoso, Maximo II DR/VR, Virtuoso II DR/VR, and Secura DR/VR Families of ICDsMedtronic, Inc.

Mounds View, MN

55112

Alternate supplier of a component plating process.
P980016/S246

7/8/10

EnTrust ICDsMedtronic, Inc.

Mounds View, MN

55112

Adding new test equipment.
P980016/S247

7/16/10

Secura DR, Secura VR, Maximo II DR, Maximo II VR, Virtuoso II DR, Virtuoso II VR, and Virtuoso ICDsMedtronic, Inc.

Mounds View, MN

55112

Changes in platinum flow on Complementary Metal Oxide Semiconductor (CMOS) at the supplier location.
P980016/S248

7/23/10

Secura DR, Secura VR, Maximo II DR, Maximo II VR, Virtuoso II DR, Virtuoso II VR Family of ICDsMedtronic, Inc.

Mounds View, MN

55112

Changes to L409 Integrated Circuit test.
P980016/S249

7/23/10

Maximo II, Secura, Virtuoso, Virtuoso II Family of ICDsMedtronic, Inc.

Mounds View, MN

55112

Update to the laser weld process.
P980016/S251

7/28/10

Secura DR/VR, Maximo II DR/VR, Entrust and Virtuoso ICDsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a software revision for a laser bonder.
P980022/S078

7/15/10

MiniLink Transmitter and iPro Digital RecorderMedtronic MiniMed

Northridge, CA

91325

Change to a new component supplier for the capacitor used in the device.
P980022/S079

7/15/10

MMT-7002 and MMT-7003 Glucose SensorsMedtronic MiniMed

Northridge, CA

91325

Modification of the GLM onto 8 plates at a time with 48 sensors per plate from 24 sensors per plate.
P980035/S172

7/8/10

EnRhythm IPGsMedtronic, Inc.

Mounds View, MN

55112

Adding new test equipment.
P980035/S174

7/16/10

Adapta/Versa/ Sensia, Relia, and EnRythm IPGsMedtronic, Inc.

Mounds View, MN

55112

Changes in platinum flow on Complementary Metal Oxide Semiconductor (CMOS) at the supplier location.
P980035/S175

7/23/10

Kappa 600/700, 650, 800/900 IPG, Relia IPG, EnPulse IPG, Adapta/Versa/ Sensia IPGMedtronic, Inc.

Mounds View, MN

55112

Addition of a new piece of equipment used in the battery burn-in process.
P980035/S176

7/28/10

EnRhythm, Relia and Adapta/Versa/ Sensia Families of IPGsMedtronic, Inc.

Mounds View, MN

55112

Additional supplier for the performance of a plating process.
P980035/S178

7/28/10

EnRhythm, Adapta/ Versa/Sensia and Relia IPGsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a software revision for a laser bonder.
P980040/S034

7/8/10

TECNIS® One-Piece Acrylic Soft Intraocular Lens (IOL) and TECNIS® Multifocal One-Piece IOLAbbott Medical Optics, Inc.

Santa Ana, CA

92705

Addition of a cosmetic inspection step to the manufacturing process of one-piece intraocular lenses.
P980043/S027

7/28/10

Hancock® II Porcine BioprosthesisMedtronic, Inc.

Santa Ana, CA

92705

Addition of a component manufacturer.
P980049/S058

7/9/10

Paradym VR/DR ICDELA Medical, Inc.

Plymouth, MN

55441

Change to in-source the micro-electronic assembly of electronic hybrid modules.
P990001/S071

7/28/10

DA+C Series and DA+T Series of IPGsMedtronic, Inc.

Mounds View, MN

55112

Additional supplier for the performance of a plating process.
P990013/S027

7/29/10

STAAR Surgical Collamer® Intraocular LensesSTAAR Surgical Company

Monrovia, CA

91016

Change of the solvent used in the dewaxing process, and to implement redesigned sieves.
P990020/S040

7/1/10

AneuRx Stent Graft SystemsMedtronic Vascular

Santa Rosa, CA

95403

Change to introduce the MicroVu measurement system for the dimensional measurements of extruded tubing.
P990033/S017

7/20/10

PepGen P-15

FLOW

Dentsply International

York, PA

17405

Use of an alternate foil pouch supplier and alternate autoclave sterilizer.
P990034/S019

7/20/10

Side Catheter Access Port KitsMedtronic Neuromodulation

Minneapolis, MN

55432

Changes to the traceability software.
P000006/S021

7/14/10

Titan Inflatable Penile Prosthesis (IPP)Coloplast Corp.

Minneapolis, MN

55411

Use of a new mold by a new vendor and modification of the current engineering drawing.
P000040/S016

7/8/10

Genesys HTA™ SystemBoston scientific Corporation

Marlborough, MA

01752

Implementation of an inspection at the cassette manufacturer and an update to a subassembly drawing.
P010013/S030

7/21/10

NovaSure® Impedance Controlled Endometrial Ablation SystemHologic, Inc.

Marlborough, MA

01752

Change in the coating of the individual conductive wires.
P010015/S090

7/8/10

Attain OTW and Attain Bipolar OTW LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new manufacturing traceability system.
P010019/S017

7/26/10

Lotrafilcon Soft Contact Lenses for Extended WearCiba Vision Corporation

Duluth, GA

30097

Changes to optical tool manufacturing.
P010031/S202

7/7/10

Concerto, Consulta, Concerto II, and Maximo II Families of CRT-DsMedtronic, Inc.

Mounds View, MN

55112

Alternate supplier of a component plating process.
P010031/S203

7/16/10

Concerto II ICD, Consulta CRT-D, Maximo II CRT-D, and ConcertoMedtronic, Inc.

Mounds View, MN

55112

Changes in platinum flow on Complementary Metal Oxide Semiconductor (CMOS) at the supplier location.
P010031/S204

7/23/10

Concerto II, Consulta, and Maximo II Family of CRT-DsMedtronic, Inc.

Mounds View, MN

55112

Changes to L409 Integrated Circuit test.
P010031/S205

7/23/10

Concerto, Concerto II, Consulta, Maximo II Family of CRT-DsMedtronic, Inc.

Mounds View, MN

55112

Update to the laser weld process.
P010031/S207

7/28/10

Concerto, Consulta, and Maximo II CRT-DsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a software revision for a laser bonder.
P020018/S036

7/15/10

Zenith Flex® AAA Endovascular Graft and Zenith Renu® AAA Ancillary

Graft with the

Z-trak® Introduction System

Cook, Inc.

Bloomington, IN

47402

Addition of a Quality Control Test to the Captor hemostatic valve tubing subassembly process.
P020047/S021

7/20/10

Multi-Link Vision® RX Coronary Stent System, Multi-Link Vision® OTW Coronary Stent System,Abbott Vascular, Inc.

Temecula, CA

92591

Increase in the minimum seal length requirement for the manufacturing of the stent delivery system.
P030009/S043

7/1/10

Driver and Micro-Driver Coronary Stent SystemsMedtronic Vascular

Santa Rosa, CA

95403

Change to introduce the MicroVu measurement system for the dimensional measurements of extruded tubing.
P030016/S015

7/29/10

STAAR Surgical Implantable Collamer® LensSTAAR Surgical Company

Monrovia, CA

91016

Change of the solvent used in the dewaxing process, and to implement redesigned sieves.
P030019/S015

7/15/10

Orthovisc High Molecular Weight HyaluronanAnika Therapeutics, Inc.

Bedford, MA

01730

Increase in storage time for depyrogenated equipment from 48 hours to 5 days.
P030031/S030

7/15/10

Celsius Thermocool Diagnostic Ablation Deflectable Tip CatheterBiosense Webster, Inc.

Diamond Bar, CA

91765

Addition of a second source supplier for the tip dome electrode.
P030035/S071

7/15/10

Frontier/Frontier II Family of CRT-PsSt. Jude Medical, Inc.

Sylmar, CA

91342

Addition of alternate suppliers for discrete components used on St. Jude Medical’s devices.
P030036/S017

7/8/10

SelectSecure LeadMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new manufacturing traceability system.
P030054/S154

7/15/10

Epic HF/Atlas+ HF Family of CRT-DsSt. Jude Medical, Inc.

Sylmar, CA

91342

Addition of alternate suppliers for discrete components used on St. Jude Medical’s devices.
P040016/S060

7/8/10

VeriFLEX™ (Liberté®) Monorail and Over-the-Wire Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Change to in-process stent inspection.
P040050/S005

7/2/10

Macroplastique® ImplantsUroplasty, Inc.

Minnetonka, MN

55343

Alternate vendor for the inner and outer Macroplastique® Implants packaging.
P050020/S024

7/9/10

FreeStyle Navigator Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc.

Alameda, CA

94502

Modification of the Injection Molded Tray which protects the Sensor Delivery Unit of the device during shipping.
P050044/S014

7/8/10

Vitagel Surgical HemostatOrthovita, Inc.

Malvern, PA

19335

Use of new packaging material for the device.
P060008/S056

7/8/10

Taxus® Liberté® Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation

Maple Grove, MN

55311

Change to in-process stent inspection.
P060027/S025

7/9/10

Paradym VR/DR ICDELA Medical, Inc.

Plymouth, MN

55441

Change to in-source the micro-electronic assembly of electronic hybrid modules.
P060033/S053

7/1/10

Endeavor Sprint Zotarolimus-Eluting Coronary Stent SystemsMedtronic Vascular

Santa Rosa, CA

95403

Change to the spray weigh system.
P060033/S056

7/1/10

Endeavor Sprint Zotarolimus-Eluting Coronary Stent SystemsMedtronic Vascular

Santa Rosa, CA

95403

Change to introduce the MicroVu measurement system for the dimensional measurements of extruded tubing.
P060038/S007

7/8/10

Mitroflow Aortic Pericardial Heart ValveSorin Group USA, Inc.

Arvada, CO

80004

Expanded use of an existing isolator.
P060039/S012

7/8/10

Attain StarFix LeadMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new manufacturing traceability system.
P070001/S007

7/2/10

ProDisc-C™ Total Disc ReplacementSynthes Spine

West Chester, PA

19380

Modified fixture used for inspection of the ProDisc-C endplates.
P070001/S008

7/2/10

ProDisc-C™ Total Disc ReplacementSynthes Spine

West Chester, PA

19380

Update to an existing holding fixture.
P070007/S019

7/1/10

Talent Thoracic Stent Graft SystemsMedtronic Vascular

Santa Rosa, CA

95403

Change to introduce the MicroVu measurement system for the dimensional measurements of extruded tubing.
P070007/S020

7/8/10

Talent Thoracic Stent Graft SystemMedtronic Vascular

Santa Rosa, CA

95403

Addition of an in-process manufacturing stent loading aid.
P070009/S010

7/26/10

Realize® Adjustable Gastric Band-CEthicon Endo-Surgery, Inc.

Cincinnati, OH

45242

Addition of an alternate sub-assembly supplier.
P070015/S039

7/23/10

XIENCE V® Everolimus-Eluting Coronary Stent System (EECSS)Abbott Vascular

Temecula, CA

92590

Modification of the stent crimp manufacturing process by eliminating the redundant inspection that occurs at the pre-crimp stage.
P070015/S040

7/20/10

XIENCE V® Everolimus-Eluting Coronary Stent System (EECSS)Abbott Vascular, Inc.

Temecula, CA

92591

Increase in the minimum seal length requirement for the manufacturing of the stent delivery system.
P070022/S005

7/21/10

Adiana Permanent Contraception SystemHologic, Inc.

Marlborough, MA

01752

Addition of incoming inspection requirements to the plastic tubing used in the matrix molding process.
P070027/S019

7/1/10

Talent Abdominal Stent Graft SystemsMedtronic Vascular

Santa Rosa, CA

95403

Change to introduce the MicroVu measurement system for the dimensional measurements of extruded tubing.
P070027/S020

7/8/10

Talent Abdominal Stent Graft SystemMedtronic Vascular

Santa Rosa, CA

95403

Addition of an in-process manufacturing stent loading aid.
P080006/S009

7/8/10

Attain Ability LeadMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new manufacturing traceability system.
P090003/S004

7/15/10

Express™ LD Iliac Premounted Stent SystemBoston Scientific

Maple Grove, MN

55311

Changes to the lap weld process and the addition of an in-process inspection specification.

Summary of PMA Originals & Supplements Approved

Originals: 1

Supplements: 63

Summary of PMA Originals Under Review

Total Under Review: 87

Total Active: 38

Total On Hold: 49

Number Greater Than 180 Days: 6

Summary of PMA Supplements Under Review

Total Under Review: 643

Total Active: 440

Total On Hold: 203

Number Greater Than 180 Days:18

Summary of All PMA Submissions Received

Originals: 7

Supplements: 71

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 63

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 121.6

FDA Time: 89.3 Days MFR Time: 32.3 Days

    

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