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PMA Final Decisions for August 2010

Wed, 09/22/2010 - 11:32am
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
P820003/S096

8/13/10

Disposable CoverMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P820003/S097

8/13/10

Disposable Cover, External Pulse Generators, Cables, Adapter, Surgical Cable, Patient Safety Cables, Disposable Pouch, SEM PrinterMedtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P820003/S098

8/18/10

External Pulse GeneratorsMedtronic, Inc.

Mounds View, MN

55112

Changes in the depaneling process for the printed circuit board assemblies.
P820033/S006

8/6/10

Plasmaflo™ OP-05W (A)Asahi Kasei Medical Co. Ltd.

Tokyo, Japan

Addition of a second process equipment set-up for certain process steps in the manufacturing of the finished device and replacement of a mold.
P830061/S053

8/13/10

CapSure SP, CapSure Sense, CapSure SP Novus, Vitatron Crystalline, Vitatron Excellence PS+, and Vitatron Excellence+ LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P830061/S054

8/13/10

CapSure Sense, CapSure SP Novus, Vitatron Crystalline, Vitatron Excellence +, and Vitatron Excellence PS+ LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P830061/S055

8/13/10

CapSure Sense, CapSure SP Novus, Vitatron Crystaline, Vitatron Excellence PS+Medtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P840001/S160

8/27/10

Spinal Cord Stimulation SystemsMedtronic, Inc.

Minneapolis, MN

55432

Changes to the test software used for electrical testing of Medtronic’s implant table neurostimulators.
P850089/S067

8/13/10

CapSure SP Z, CapSure Z Novus, CapSure SP Novus, Vitatron Excellence S+, Vitatron Excellence S++, Vitatron Impulse, and Vitatron Impulse II LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P850089/S068

8/13/10

CapSure Z Novus, CapSure SP Novus, Vitatron Excellence S+, Vitatron Excellence S++, Vitatron Impulse, and Vitatron Impulse II LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P850089/S069

8/13/10

CapSure SP Z Leads, CapSure Z Novus, CapSure SP Novus, Vitatron Excellence SS+, and Vitatron Impulse IIMedtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P860019/S259

8/13/10

Apex™ Monorail™ and Maverick 2 PTCA CathetersBoston Scientific Corporation

Maple Grove, MN

55311

Change to equipment used for sealing the pouches in which the finished devices are packaged.
P890003/S196

8/13/10

ECG Cable, CapSure VDD, Vitatron Brilliant S+ VDD, Vitatron Legacy, Vitatron Legacy II, and Vitatron Visa LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P890003/S197

8/13/10

Wrench Kit, CapSure VDD, and Vitatron Brilliant S+ VDD LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P890003/S198

8/13/10

CapSure, Brilliant S+ VDD Leads, Prodigy SR, Wrench Kit, Thera-i,

Vitatron Legacy, Vitatron Legacy II, Vitatron Visa, Pacing System

Analyzer, CareLink Monitor, Patient Cable, Analyze Cable, Cables,

Wireless PC card, Xircom Modem, Xircom Combination

Ethernet/Modem Card, ECG Slave Cable, ECG Slave Cable Adaptor, BatteryCheck Monitor, CardioSight Reader, Connector

Port Pin-Plug, Analyzer, Adaptor, Telemetry Programming Head,

Programming Head for 2090, Programming Head for 9790, Patient

Magnet, Programmer, and CareLink Programmer

Medtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P900056/S102

8/26/10

Rotablator™ Rotational Angioplasty System RotaLink™ Plus, RotaLink Exchangeable CatheterBoston Scientific

Maple Grove, MN

55311

Alternate processing materials, and an alternate vendor used to manufacture a component of the Rotablator series of devices.
P900061/S092

8/13/10

Ace Header, Lead End Pin Cap, Upsizing Sleeve, and Transvene Defibrillation LeadMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P900061/S093

8/13/10

Accessory (Upsizing Sleeve) and Lead End Pin CapMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P900061/S094

8/13/10

Accessory (upsizing sleeve), Accessory (upsizing sleeve) for

Unipolar, GEM, PCD Tachy Control System, Jewel, Lead End Pin

Cap, Micro Jewel, Micro Jewel II, Transvene Defibrillation Lead,

External Tachyarrhythmia Control Device (ETCD), Defibrillation

Support.Device (DISD), Patient Magnet, Ace Header, Cables,

Connectors, and Test Load

Medtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P900066/S010

8/18/10

ISPAN Perfluoropropane C3F8 GasAir Liquide Healthcare America Corporation

Plumsteadville, PA

18949

Change of the cleaning solvent used in the perfluoropropane gas manufacturing process.
P910023/S241

8/6/01

Cadence and Current Family of ICDsSt. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Use of alternate cleaning equipment.
P910023/S242

8/6/01

Cadence/Epic/Atlas/Current/Fortify Families of ICDsSt. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Hardware changes to an automated test system used in the capacitor manufacturing process.
P910023/S244

8/13/10

Cadence/Current Families of ICDsSt. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Reduction in receiving inspection sample sizes for components used in the manufacturing of capacitors.
P910023/S245

8/13/10

Cadence, Current, and Fortify Family of ICDsSt. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Use of alternate inspection equipment used in the manufacture of hybrid components.
P910023/S247

8/27/10

Cadence Family of ICDsSt. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Addition of alternate suppliers for a diode component and an organic substrate.
P910073/S085

8/13/10

Endotak Reliance Family of LeadsBoston Scientific CRV

St. Paul, MN

55112

Change in the receiving inspection sampling plan for trilumen silicone tubing.
P910077/S106

8/13/10

Ventak Mini IV ICDBoston Scientific Corporation

St. Paul, MN

55112

Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays.
P920015/S062

8/5/10

Sprint Quattro LeadMedtronic, Inc.

Mounds View, MN

55112

New silicone mold for the shaft seal component.
P920015/S063

8/13/10

Lead Adaptor, Y Adaptor, Tunneling Tool, IS-1 Connector Port Pin Plug Kit, Transvene SVC, Sprint Quattro, Sprint Quattro Secure, Sprint Quattro Single Coil and Subcutaneous Defibrillation LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P920015/S064

8/13/10

IS-1 Connector Port Pin Plug Kit, Transvene SVC, Subcutaneous Defibrillation, Sprint Quattro, Sprint Quattro Secure, and Sprint Quattro Single Coil LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P920015/S065

8/13/10

IS-1 Connector Port Pin Plug Kit, Sprint Quattro, Sprint Quattro Secure, Subcutaneous Lead, Sub-Q Tunneling Tool, Transvene SVC Lead, Lead Adaptor, DF-1 Y Adaptor, Pacer- Cardioverter

Defibrillator

Medtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P920047/S043

8/26/10

Blazer II and Blazer Prime HTD Cardiac Ablation CathetersBoston Scientific Corporation

San Jose, CA

95134

Change in the application of the current shrink tubing process.
P930029/S024

8/13/10

RF Marinr, RF Marinr NTC, 5F RF Marinr, RF Conductr, RF Enhancr II, and RF Contactr RF Ablation CathetersMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P930029/S025

8/13/10

RF Marinr, RF Marinr NTC, 5F RF Marinr, RF Conductr, RF Enhancr II, and RF ContactrMedtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P930038/S063

8/27/10

Angio-Seal™ Vascular Closure DeviceSt. Jude Medical

St. Paul, MN

55117

Alternate sterilization inspection method.
P930039/S040

8/13/10

CapSure Fix Novus, SureFix, CapSure Fix, Vitatron Crystalline ActFix, Vitatron Pirouet+, and Vitatron Pirouet S+ LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P930039/S041

8/13/10

CapSure Fix Novus, SureFix, CapSure Fix, Vitatron Crystalline ActFix, and Vitatron Pirouet S+ LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P930039/S042

8/13/10

CapSureFix, CapSureFix Novus, SureFix, Vitatron Crystalline ActFix, and Vitatron Pirouet SMedtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P930039/S043

8/27/10

CapSure Pacing LeadMedtronic, Inc.

Mounds View, MN

55112

Use of a new electrical test fixture.
P940031/S068

8/13/10

Pulsar Max, Meridian, and Discovery PacemakersBoston Scientific Corporation

St. Paul, MN

55112

Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays.
P950021/S012

8/30/10

ADVIA Centaur PSA ImmunoassaySiemens Healthcare Diagnostics

E. Walpole, MA

02032

Implementation of an automated process for making a component that is common to the PSA and cPSA assays.
P950024/S022

8/13/10

CapSure EPI Unipolar and Bipolar LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P950024/S023

8/13/10

CapSure EPI Unipolar and Bipolar LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P950024/S024

8/13/10

CapSure Epicardial Pacing LeadMedtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P960007/S019

8/25/10

TransCyte Human Fibroblast-Derived Temporary SkinAdvanced BioHealing, Inc.

La Jolla, CA

92037

Eliminating an assay used in the TransCyte manufacturing process.
P960009/S091

8/27/10

Activa Deep Brain Stimulation (DBS)Medtronic, Inc.

Minneapolis, MN

55432

Changes to the test software used for electrical testing of Medtronic’s implant table neurostimulators.
P960016/S030

8/13/10

Livewire TC Cardiac Ablation SystemAtrial Fibrillation Division

Minnetonka, MN

55345

Replacement of the RF Flaring Fixture with a Thermal Flaring Fixture.
P960016/S031

8/13/10

Livewire TC™ Cardiac Ablation SystemS. Jude Medical, Inc.

Minnetonka, MN

55345

Change to the wire-to-ring brazing process.
P960040/S226

8/13/10

Teligen, Confient, Ventak Prizm HE/AT, Ventak Prizm 2, Vitality DS/DS VR/EL, Vitality HE, Vitality AVT, and Vitality 2 ICDsBoston Scientific Corporation

St. Paul, MN

55112

Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays.
D970003/S121

8/13/10

Insignia Ultra/Plus/Entra, Altrua 20/40/60, Pulsar Max II, Meridian II, Discovery II, Intelis II, and Nexus PacemakersBoston Scientific Corporation

St. Paul, MN

55112

Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays.
P970012/S072

8/13/10

Kappa 400 IPGsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P970012/S073

8/13/10

Kappa 400 DR, Kappa 400 SR, and Remote AssistantMedtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P970012/S074

8/27/10

Kappa 400 DR, Kappa 400 SR IPGsMedtronic, Inc.

Mounds View, MN

55112

Relocation of an ethylene oxide sterilizer.
D970012/S077

8/26/10

AMS Model 700 Inflatable Penile ProsthesisAmerican Medical Systems

Minnetonka, MN

55343

Change to an in-process manufacturing test.
D970012/S078

8/26/10

AMS Model 700 Inflatable Penile ProsthesisAmerican Medical Systems

Minnetonka, MN

55343

Upgrading of certain components used in the INHIBIZONE (IZ) treatment process.
P980016/S253

8/13/10

CapSure Fix Lead, Maximo, Marquis, Intrinsic, EnTrust, and Virtuoso ICDsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P980016/S254

8/13/10

CapSure, Entrust, Gem, Gem II, Gem III, Intrinsic, Marquis, Maximo, Maximo II, Onyx, Secura, Virtuoso, and Virtuoso IIMedtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P980016/S256

8/20/10

Secura DR/VR, Maximo II DR/VR, Virtuoso II VR/DR, Marquis, Maximo, Intrinsic, Virtuoso, EnTrust ICDsMedtronic, Inc.

Mounds View, MN

55112

Upgrade to the capacitors helium leak test station.
P980016/S257

8/26/10

Virtuoso,

Secura DR/VR, Maximo II DR/VR, and Virtuoso DR/VR ICDs

Medtronic, Inc.

Mounds View, MN

55112

Change in the Laser Ribbon Bonding (LRB) manufacturing process.
P980016/S258

8/27/10

GEM II, Marquis, Maximo, Intrinsic, Entrust, Virtuoso, Maximo II DR/VR, Virtuoso II DR/VR, Secura DR/VR Family of ICDsMedtronic, Inc.

Mounds View, MN

55112

Relocation of an ethylene oxide sterilizer.
P980035/S179

8/13/10

EnPulse, Kappa 700/800/900, Adapta, Sigma, Relia, Sensia, and Versa IPGsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P980035/S180

8/13/10

350 Series, Adapta, AT500, EnPulse, EnRhythm, Kappa 600/500, Kappa 700, Kappa 800, Kappa 900, Relia, Sensia, Versa, Sigma, and Patient ActibatorMedtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P980035/S181

8/13/10

Adapta/Versa/ Sensia, Relia IPG Family of DevicesMedtronic, Inc.

Mounds View, MN

55112

Addition of an automatic optical inspection (AOI) system.
P980035/S183

8/25/10

EnRhythm IPGsMedtronic, Inc.

Mounds View, MN

55112

Correction to testing procedures at a component supplier.
P980035/S184

8/27/10

Kappa 600/700, 650, 800/900, Relia, Sigma, Medtronic 350, EnPulse, EnRhythm, AT500, Adapta, Versa, and Sensia Family of IPGsMedtronic, Inc.

Mounds View, MN

55112

Relocation of an ethylene oxide sterilizer.
P980035/S185

8/27/10

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

Mounds View, MN

55112

Optimization of weld process parameters.
P980050/S051

8/13/10

DX-SVC Transvene LeadMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P980050/S052

8/13/10

CS-SVC Transvene LeadMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P980050/S053

8/13/10

Jewel AF, GEM II AT, CS-SVC Transvene Lead and InCheck Patient AssistantMedtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P990001/S073

8/13/10

DA+ C-Series and DA+ T-SeriesMedtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P990001/S074

8/25/10

C-Series and T-Series IPGsMedtronic, Inc.

Mounds View, MN

55112

Correction to testing procedures at a component supplier.
P990001/S075

8/27/10

Kappa 400 DR, Kappa 400 SR IPGsMedtronic, Inc.

Mounds View, MN

55112

Relocation of an ethylene oxide sterilizer.
P990013/S026

8/26/10

STAAR Surgical Collamer® Intraocular LensesSTAAR Surgical Company

Monrovia, CA

91016

Relocation of the Glebar Centerless Grinder and Specialty Machine Slicer.
P990013/S028

8/26/10

STAAR Surgical Collamer® Intraocular LensesSTAAR Surgical Company

Monrovia, CA

91016

Change to the aluminum crimp caps used as part of the packaging for the IOLs.
P990055/S013

8/30/10

ADVIA Centaur cPSA ImmunoassaySiemens Healthcare Diagnostics

E. Walpole, MA

02032

Implementation of an automated process for making a component that is common to the PSA and cPSA assays.
P000014/S021

8/19/10

VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and CalibratorOrtho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Additional supplier and an update of the raw material documentation for the supply of human, defibrinated, anti-HBs negative plasma used to manufacture the device.
P000040/S017

8/20/10

Genesys/HTA™ SystemBoston Scientific Corp.

Marlborough, MA

01752

Qualification of a secondary alternative supplier for two components.
P000044/S024

8/30/10

VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator; HBsAg Confirmatory KitOrtho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Use of an additional supplier of the material used as mouse monoclonal anti-HBs antibody and update of the raw material of the mouse monoclonal anti-HBs antibody and manufacturing documentation of the VITROS HBsAg Conjugate Reagent.
P000053/S029

8/26/10

AMS 800 Artificial Urinary SphincterAmerican Medical Systems

Minnetonka, MN

55343

Upgrading of certain components used in the INHIBIZONE (IZ) treatment process.
P010012/S246

8/13/10

Cognis, Livian, Contak Renewal, Contak Renewal 3/3 HE, Contak Renewal 3 RF/3RF HE, and Contak Renewal 3 AVT CRT-DsBoston Scientific Corporation

St. Paul, MN

55112

Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays.
P010015/S094

8/13/10

Attain LV, CS and OTW LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P010015/S095

8/13/10

Attain LV and CS LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P010015/S096

8/13/10

Attain InSync, and InSync IIIMedtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P010015/S098

8/27/10

InSync and InSync III Family of

CRT-Ps

Medtronic, Inc.

Mounds View, MN

55112

Relocation of an ethylene oxide sterilizer.
P010031/S209

8/13/10

InSync Sentry and Maximo ICDsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P010031/S210

8/13/10

Concerto, Concerto II, Consulta, InSync ICD, InSync Marquis, InSync Maximo, InSync II Marquis, Maximo II, InSync II Protect, InSync II Marquis, InSync Sentry, and Conexus ActivatorMedtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P010031/S212

8/20/10

InSync Sentry ICD, InSync III Marquis ICD, InSync II Marquis ICD, InSync Maximo ICD, Concerto ICD, Consulta CRT-D, Maximo II CRT-D, Concerto II CRT-DMedtronic, Inc.

Mounds View, MN

55112

Upgrade to the capacitors helium leak test station.
P010031/S213

8/26/10

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

Mounds View, MN

55112

Change in the Laser Ribbon Bonding (LRB) manufacturing process.
P010031/S214

8/27/10

InSync, InSync Marquis, InSync II Marquis, InSync III Marquis, InSync II Protect, InSync Sentry, InSync Maximo Family of ICDs; Concerto, Concerto II, Maximo II, Consulta Family of CRT-DsMedtronic, Inc.

Mounds View, MN

55112

Relocation of an ethylene oxide sterilizer.
P010047/S004

8/5/10

NeoMend ProGel™ Surgical SealantNeoMend, Inc.

Irvine, CA

92618

Change in the location of the contract manufacturer of one of the components.
P020004/S054

8/6/10

Gore® Excluder® AAA EndoprosthesisW.L. Gore & Associates

Flagstaff, AZ

86002

Addition of a machine for electropolishing nitinol wire.
P020025/S024

8/26/10

Blazer II XP and Blazer Prime XP Cardiac Ablation CathetersBoston Scientific Corporation

San Jose, CA

95134

Change in the application of the current shrink tubing process.
P020026/S080

8/6/10

CYPHER® Sirolimus-Eluting Coronary Stent on RAPTORRAIL® Rapid Exchange Delivery SystemCordis Corporation

Miami Lakes, FL

33014

Change in overage for the spray coating process.
P020036/S018

8/27/10

Smart® Nitinol Stent System and Smart® Control Nitinol Stent SystemCordis Corporation

Miami Lakes, FL

33014

Addition of an in-process inspection.
P030005/S065

8/13/10

Contak Renewal TR CRT-PsBoston Scientific Corporation

St. Paul, MN

55112

Revision of inspection procedures for ceramic capacitors, ceramic networks, and ceramic capacitor arrays.
P030016/S014

8/26/10

STAAR Surgical Implantable Collamer® LensSTAAR Surgical Company

Monrovia, CA

91016

Relocation of the Glebar Centerless Grinder and Specialty Machine Slicer.
P030016/S016

8/26/10

STAAR Surgical Implantable Collamer® LensSTAAR Surgical Company

Monrovia, CA

91016

Change to the aluminum crimp caps used as part of the packaging for the IOLs.
P030036/S019

8/13/10

Anchoring Sleeve Kit and SelectSecure LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P030036/S020

8/13/10

Anchoring Sleeve KitMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P030036/S021

8/13/10

SelectSecure and Anchoring Sleeve KitMedtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P030047/S021

8/27/10

Precise®, Precise® RX and Precise® PRO Rx Nitinol Stent SystemCordis Corporation

Miami Lakes, FL

33014

Addition of an in-process inspection.
P030054/S160

8/6/01

Epic, Atlas and Promote Family of CRT-DsSt. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Use of alternate cleaning equipment.
P030054/S161

8/6/01

Epic/Atlas/Promote/Unify Families of CRT-DsSt. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Hardware changes to an automated test system used in the capacitor manufacturing process.
P030054/S163

8/13/10

Epic/Atlas/Promote/Unify Families of CRT-DsSt. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Reduction in receiving inspection sample sizes for components used in the manufacturing of capacitors.
P030054/S164

8/13/10

Epic/Atlas/Promote/Unify Families of CRT-DsSt. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Use of alternate inspection equipment used in the manufacture of hybrid components.
P030054/S166

8/27/10

Epic HF/Atlas+ HF Family of CRT-DsSt. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Addition of alternate suppliers for a diode component and an organic substrate.
P040016/S061

8/13/10

VeriFLEX (Liberté) Stent Delivery SystemBoston Scientific Corporation

Maple Grove, MN

55311

Change to equipment used for sealing the pouches in which the finished devices are packaged.
P040024/S049

8/12/10

Restylane® Injectable GelMedicis Pharmaceutical Corporation

Scottsdale, AZ

85256

Change in fill volume for Restylane®-L.
P040027/S020

8/6/10

Gore® Viatorr® TIPS EndoprosthesisW.L. Gore & Associates

Flagstaff, AZ

86002

Addition of a machine for electropolishing nitinol wire.
P040037/S027

8/6/10

Gore® Viabahn® EndoprosthesisW.L. Gore & Associates

Flagstaff, AZ

86002

Addition of a machine for electropolishing nitinol wire.
P040043/S035

8/6/10

Gore® TAG® Thoracic EndoprosthesisW.L. Gore & Associates

Flagstaff, AZ

86002

Addition of a machine for electropolishing nitinol wire.
P050006/S017

8/6/10

Gore® Helex Septal OccluderW.L. Gore & Associates

Flagstaff, AZ

86002

Addition of a machine for electropolishing nitinol wire.
P050012/S028

8/25/10

DexCom Seven and Seven Plus Continuous Glucose Monitoring

Systems

DexCom, Inc.

San Diego, CA

92121

Use of a secondary porous pouch sealer for the SEVEN Sensors which are components of the Seven and Seven Plus Continuous Glucose Monitoring Systems.
P050012/S029

8/25/10

DexCom Seven and Seven Plus Continuous Glucose Monitoring

Systems

DexCom, Inc.

San Diego, CA

92121

Change to reduce the hold time after adhesive is applied to attach the adhesive patch to the disposable housing for the Seven and Seven Plus Continuous Glucose Monitoring Systems.
P050012/S032

8/25/10

DexCom Seven and Seven Plus Continuous Glucose Monitoring

Systems

DexCom, Inc.

San Diego, CA

92121

Change to the manufacture of the DexCom Seven and Seven Plus System Receiver to improve the manufacturing consistency of the receiver component of the device.
P050023/S036

8/20/10

Lumax Families of ICDs and CRT-DsBiotronik, Inc.

Lake Oswego, OR

97035

New supplier of a communication component.
P050028/S008

8/30/10

COBAS AmpliPrep/ COBAS TaqMan HBV TestRoche Molecular Systems, Inc.

Pleasanton, CA

94588

Scale-up of a manufacturing process.
P060002/S013

8/13/10

Bard® FLAIR® Endovascular Stent GraftBard Peripheral Vascular, Inc.

Tempe, AZ

85280

Software upgrade and an improvement to the tape wrapping process.
P060002/S014

8/13/10

Bard Flair® Endovascular Stent GraftBard Peripheral Vascular, Inc.

Tempe, AZ

85280

Revised formulation for the adhesive used during manufacturing.
P060030/S012

8/30/10

COBAS AmpliPrep/ COBAS TaqMan HCV TestRoche Molecular Systems, Inc.

Pleasanton, CA

94588

Scale-up of a manufacturing process.
P060039/S014

8/13/10

Attain StarFix LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P060039/S015

8/13/10

Attain StarFix LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.
P070015/S041

8/13/10

XIENCE V® Everolimus-Eluting Coronary Stent System and PROMUS™ Everolimus-Eluting Coronary Stent SystemAbbott Vascular

Temecula, CA

92591

Inclusion of filter integrity testing to the manufacturing process.
P070015/S042

8/26/10

XIENCE V® Everolimus-Eluting Coronary Stent System and PROMUS™ Everolimus-Eluting Coronary Stent SystemAbbott Vascular

Temecula, CA

92591

Change to stability testing frequency.
P070015/S043

8/27/10

XIENCE V® Everolimus-Eluting Coronary Stent System and PROMUS™ Everolimus-Eluting Coronary Stent SystemAbbott Vascular

Temecula, CA

92591

Use of a new final stent crimping machine.
P080006/S011

8/5/10

Attain Ability Family of LeadsMedtronic, Inc.

Mounds View, MN

55112

Transfer of the laser ablation process, the addition of new laser ablation equipment, and changes in the ablation process.
P080006/S012

8/13/10

Attain Ability LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of a new version of traceability software.
P080006/S013

8/13/10

Attain Ability LeadsMedtronic, Inc.

Mounds View, MN

55112

Implementation of an electronic system for incoming inspection data.

Summary of PMA Originals & Supplements Approved

Originals: 1

Supplements: 39

Summary of PMA Originals Under Review

Total Under Review: 89

Total Active: 39

Total On Hold: 50

Number Greater Than 180 Days: 5

Summary of PMA Supplements Under Review

Total Under Review: 657

Total Active: 440

Total On Hold: 217

Number Greater Than 180 Days: 18

Summary of All PMA Submissions Received

Originals: 3

Supplements: 64

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 39

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 139.87

FDA Time: 89.85 Days MFR Time: 50.3 Days

    

SOURCE

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