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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
P060029

6/3/10

Omnex Surgical Sealant Ethicon, Inc.

Somerville, NJ

08876

Approval for the Ethicon Omnex Surgical Sealant. The device is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
P080027

6/25/10

OraQuick Rapid HCV Antibody Test OraSure Technologies, Inc.

Bethlehem, PA

18015

Approval for the OraQuick Rapid HCV Antibody Test. The device is indicated for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in venipuncture whole blood specimens (EDTA, sodium heparin, lithium heparin, and sodium citrate) from individuals 15 years or older. The OraQuick® HCV Rapid antibody Test results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with HCV (state of infection or associated disease not determined) in persons with signs or symptoms of hepatitis and in persons at risk for hepatitis C infection.
APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P790017/S104

6/4/10

135-Day

Gruntzig Dilaca Balloon Dilatation Catheter Medtronic Vascular, Inc.

Santa Rosa, CA

95403

Approval for a change to the balloon subassembly manufacturing process.
P810046/S237

6/1/10

Real-Time

Voyager NC Coronary Dilatation Catheter Abbott Vascular, Inc.

Temecula, CA 92591

Approval for a change in the in-process extruded balloon tubing outer diameter.
P860057/S068

6/24/10

Real-Time

Carpentier-Edwards® PERIMOUNT® Magna Mitral Ease™ Pericardial Bioprostheses Edwards Lifesciences LLC

Irvine, CA

92614

Approval for a new mitral valve model to be added to the Carpentier-Edwards® PERIMOUNT® valve series, which incorporates a new suture guide line, a hybrid clip, a modified jar, a modified sleeve, a hybrid holder, and modified accessories. The device, as modified, will be marketed under the trade name Carpentier-Edwards® PERIMOUNT® Magna Mitral Ease™ Pericardial Bioprostheses, Models 7300 & 7300TFX, and is indicated for patients who require replacement of their native or prosthetic mitral valve.
P910018/S013

6/18/10

180-Day

Blood Tubing System for the Liposorber LA-15 System Kaneka Pharma America LLC

New York, NY

10036

Approval for a manufacturing site located at M.E. Nikkiso Co., LTD, Chacheongsao, Thailand.
P910023/S229

6/28/10

135-Day

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

Sunnyvale, CA

94085

Approval for an alternate supplier of an electronic assembly module.
P910023/S232

6/22/10

Real-Time

Current & Fortify ICD Family St. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Approval for a labeling change from SJ-4 to DF-4 for St. Jude Medical high voltage lead, implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) products.
P950022/S070

6/22/10

Real-Time

Durata Lead Family St. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Approval for a labeling change from SJ-4 to DF-4 for St. Jude Medical high voltage lead, implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) products.
P950029/S048

6/18/10

Real-Time

Reply ELA Medical, Inc./ Sorin Group

Plymouth, MN

55441

Approval for software versions W1.5.2 and W1.5.3 for the Reply Pacemaker.
P950029/S049

6/18/10

Real-Time

Reply (V2) and Esprit ELA Medical, Inc./ Sorin Group

Plymouth, MN

55441

Approval for software versions W2.7.3 and W2.7.4 for the Reply (V2) and Esprit Pacemakers.
P950029/S053

6/28/10

Real-Time

Programmer Software Version Smartview 2.20UG1 for Reply and Esprit Pacemakers ELA Medical, Inc./ Sorin Group

Plymouth, MN

55441

Approval for Programmer Software Version Smartview 2.20UG1 for use with the Ovation and Paradym ICDs and CRT-Ds and the Reply and Esprit Pacemakers.
P950037/S081

6/18/10

Real-Time

CardioMessenger-S and CardioMessenger-S TLine Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the CardioMessenger-S and CardioMessenger-S TLine.
P960009/S073

6/1/10

180-Day

Medtronic Neuromodulation Deep Brain Stimulation Systems Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for revised labeling for the device. The changes consist of organization, editorial, and content revisions, which include the addition of new warnings and contraindications.
P960009/S083

6/28/10

Real-Time

Activa PC and Activa RC Neurostimulators Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for minor firmware design changes to automate the handling of most POR (power on reset) events in the “Activa RC and Activa PC neurostimulator.
P960011/S017

6/15/10

135-Day

BD1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid) Ferring Pharmaceuticals, Inc.

Parsippany, NJ

07054

Approval for a change in manufacture using new equipment.
P960016/S029

6/25/10

Special

Livewire TC™ and Safire™ Ablation Catheters St. Jude Medical

Minnetonka, MN

55345

Approval for modifications to the Instructions for Use.
P960028/S032

6/29/10

135-Day

Soft Acrylic Intraocular Lenses, ReZoom Lens Abbott Medical Optics, Inc.

Santa Ana, CA

92705

Approval for a change in the cycle time for the Tumbling process.
P960058/S080

6/11/10

180-Day

Harmony HiResolution Bionic Ear System Advanced Bionics, LLC

Sylmar, CA

91342

Approval for the addition of a moisture getter material in the HiRes90KL cochlear implant as a preventive measure in the unlikely event of a hermetic failure.
P970018/S021

6/30/10

Real-Time

PrepStain™ System BD Diagnostics

Durham, NC

27703

Approval for changes made to the PrepStain software to reflect customer preference for “Prep Only” processing.
P970051/S053

6/3/10

180-Day

Nucleus Cochlear Implant System Cochlear Americas

Centennial, CO 80111

Approval for the Compact (A26) and Standard (A27) lithium-ion rechargeable batteries for use with the CP810 sound processor in the Behind-The-Ear (BTE) configuration.
P980022/S069

6/3/10

Real-Time

Paradigm Real-Time Pump Medtronic, Inc.

Northridge, CA 91325

Approval for minor modifications to the pump drive screw weld. The device is indicated for continuous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
P980022/S073

6/29/10

Real-Time

CareLink™ Personal Therapy Management Software for Diabetes (DEV-0016) Medtronic, Inc.

Northridge, CA 91325

Approval for a change to the CareLink Personal Therapy Management Software for Diabetes (DEV-0016). The software version 1.0A is a revision to implement several feature enhancements and correction of three minor anomalies.
P980035/S153

6/18/10

180-Day

EnRhythm, Adapta, Versa, Sensia, and Relia IPG Medtronic, Inc.

Mounds View, MN

55112

Approval for the manufacturing and design change to XC202 Ceramic Capacitor of the devices.
P980040/S030

6/29/10

135-Day

AMO Sensar Soft Acrylic Intraocular Lenses, Tecnis 1-Piece Intraocular Lenses Abbott Medical Optics, Inc.

Santa Ana, CA

92705

Approval for a change in the cycle time for the Tumbling process.
P980049/S057

6/28/10

Real-Time

Programmer Software Version Smartview 2.20UG1 for Ovation ICDs and CRT-Ds ELA Medical, Inc./ Sorin Group

Plymouth, MN

55441

Approval for Programmer Software Version Smartview 2.20UG1 for use with the Ovation and Paradym ICDs and CRT-Ds and the Reply and Esprit Pacemakers.
P990080/S033

6/29/10

135-Day

AMO Tecnis Intraocular Lenses Abbott Medical Optics, Inc.

Santa Ana, CA

92705

Approval for a change in the cycle time for the Tumbling process.
P000008/S018

6/18/10

Special

LAP BAND® Adjustable Gastric Banding (LAGB) System Allergan, Inc.

Goleta, CA

93117

Approval to modify the Instructions for Use to add “data from a post-approval study showed an estimated explant rate of 6.5% per year over the first five years following implantation” to the Adverse Events section.
P000026/S003

6/17/10

Real-Time

AquaFlow™ Collagen Glaucoma Drainage Devices STAAR Surgical Company

Monrovia, CA

91016

Approval for a minor labeling change for the device.
P000029/S065

6/1/10

180-Day

Deflux® Injectable Gel Oceana Therapeutics, Inc.

Edison, NJ

08817

Approval for changing the sterilization method to gamma radiation, changing the packaging materials, and outsourcing the manufacturing of the Deflux needle component.
P000041/S009

6/10/10

180-Day

OnGuard v5.1 Riverain Medical Group, LLC

Miamisburg, OH

45342

Approval for the OnGuard 5.1 CADe software.
P020026/S070

6/15/10

135-Day

CYPHER® Sirolimus-Eluting Coronary Stent System on RAPTOR™ Over-the-Wire Delivery System Cordis Corporation

Miami Lakes, FL

33014

Approval for an alternate test method for conducting drug uniformity testing.
P020026/S079

6/24/10

180-Day

CYPHER® Sirolimus-Eluting Coronary Stent System on RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL Rapid Exchange Delivery System Cordis Corporation

Miami, FL

33102

Approval for updates to the Instructions for Use.
P020047/S017

6/22/10

180-Day

Multi-Link 8 and Multi-Link 8 Long Lesion Coronary Stent System Abbott Vascular

Santa Clara, CA

95054

Approval for the Multi-Link 8 and Multi-Link 8 Long Lesion Coronary Stent System.
P020052/S006

6/25/10

Special

Response CV Cardioversion Electrophysiology Catheter with Lumen St. Jude Medical

Minnetonka, MN

55345

Approval for modifications to the Instructions for Use.
P030009/S038

6/4/10

135-Day

Driver and MicroDriver Coronary Stent Systems Medtronic Vascular, Inc.

Santa Rosa, CA

95403

Approval for a change to the balloon subassembly manufacturing process.
P030017/S031

6/15/10

180-Day

Precision Spinal Cord Stimulator (SCS) System Boston Scientific

Valencia, CA

91355

Approval for the modification of the OR Cable and inspection tool.
P030017/S033

6/15/10

180-Day

Precision Spinal Cord Stimulator (SCS) System Boston Scientific

Valencia, CA

91355

Approval for the update to the Clinician Programmer laptop computer used with the Precision® System.
P030017/S035

6/15/10

180-Day

Precision Spinal Cord Stimulator (SCS) System Boston Scientific

Valencia, CA

91355

Approval for the modification of the inner sterile tray cover.
P030017/S037

6/15/10

Real-Time

Precision Spinal Cord Stimulator (SCS) System Boston Scientific

Valencia, CA

91355

Approval for the IPG and Lead Extension Connector Spring Contact.
P030017/S053

6/15/10

180-Day

Precision Spinal Cord Stimulator (SCS) System Boston Scientific

Valencia, CA

91355

Approval for IPG/ETS Firmware Revision 3.02.
P030017/S065

6/15/10

180-Day

Precision Spinal Cord Stimulator (SCS) System Boston Scientific

Valencia, CA

91355

Approval for the Bionic Navigator Software Version 1.2.
P030017/S071

6/1/10

180-Day

Precision Spinal Cord Stimulator (SCS) System Boston Scientific

Valencia, CA

91355

Approval for adding an undercut on the feedthrough where the header attaches.
P030017/S082

6/1/10

Real-Time

Precision Spinal Cord Stimulator (SCS) System Boston Scientific

Valencia, CA

91355

Approval for substituting a new type of polymide tape.
P030017/S084

6/1/10

Real-Time

Precision Spinal Cord Stimulator (SCS) System Boston Scientific

Valencia, CA

91355

Approval for the use of PETG, a new type of battery insulation material.
P030017/S093

6/8/10

180-Day

Precision Spinal Cord Stimulator (SCS) System Boston Scientific

Valencia, CA

91355

Approval for two versions of a Lead Extension “Splitter 2x4”: the “Distal 4” or “D4” (SWC-3304-25) and the “Wide 4” or “W4” (SC-3354-25).
P030017/S095

6/1/10

180-Day

Precision Spinal Cord Stimulator (SCS) System Boston Scientific

Valencia, CA

91355

Approval for an update to the Clinician Programmer tablet laptop (Toshiba model M750) computer.
P030025/S080

6/11/10

135-Day

Taxus® Express 2® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for a change from a manual to an automated coating process.
P030031/S024

6/28/10

135-Day

NaviStar® RMT Thermocool® Diagnostic/Ablation Deflectable Tip Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for a test method change for the final inspection flow and leak test.
P030042/S003

6/21/10

180-Day

Conserve Plus Hip Resurfacing System Wright Medical Technology, Inc.

Arlington, TN

38002

Approval of the post-approval study protocol.
P030054/S144

6/28/10

135-Day

Epic HF Family of CRT-Ds St. Jude Medical Cardiac Rhythm Management Division

Sunnyvale, CA

94085

Approval for an alternate supplier of an electronic assembly module.
P030054/S148

6/22/10

Real-Time

Promote & Unify CRT-D Family St. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Approval for a labeling change from SJ-4 to DF-4 for St. Jude Medical high voltage lead, implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) products.
P040001/S017

6/2/10

180-Day

X-STOP Interspinous Process Device Medtronic Spine LLC

Sunnyvale, CA

94089

Approval of the post-approval study protocol.
P040005/S004

6/29/10

135-Day

HER2 FISH pharmDx™ Kit Dako Denmark A/S

Glostrup, Denmark

DK-2600

Approval to add an alternate supplier and change an in-process QC.
P040016/S047

6/11/10

135-Day

VeriFLEX™ (Liberté®) Bare Metal Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for a change from a manual to an automated coating process.
P040023/S015

6/4/10

135-Day

Duraloc® Option Ceramic Hip System DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for a manufacturing process change to the grit blast operation for the porous coated Summit Hip femoral prosthesis.
P040025/S010

6/28/10

Real-Time

Olympic Cool-Cap® Natus Medical, Inc.

Seattle, WA

98108

Approval for the Olympic Cool-Cap System software version 2.0.
P040036/S017

6/28/10

135-Day

NaviStar® RMT Thermocool® Diagnostic/Ablation Deflectable Tip Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for a test method change for the final inspection flow and leak test.
P040044/S032

6/17/10

Special

Mynx Vascular Closure Device Access Closure, Inc.

Mountain View, CA

94043

Approval for changes to the Instructions for Use to apply light fingertip compression proximal to the insertion site before deflating and removing the balloon catheter.
P040048/S009

6/4/10

180-Day

Triology AB Acetabular Hip Zimmer, Inc.

Warsaw, IN

46581

Approval of the post-approval study protocol.
P050023/S031

6/18/10

Real-Time

CardioMessenger-S and CardioMessenger-S TLine Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the CardioMessenger-S and CardioMessenger-S TLine.
P060008/S013

6/28/10

180-Day

Taxus® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Approval of the post-approval study protocol.
P060008/S035

6/11/10

135-Day

Taxus® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for a change from a manual to an automated coating process.
P060025/S006

6/17/10

Special

ATS 3f® Aortic Bioprosthesis ATS Medical

Lake Forest, CA

92630

Approval for revised instructions for use.
P060027/S024

6/28/10

Real-Time

Programmer Software Version Smartview 2.20UG1 for Paradym and Ovatio ICDs and CRT-Ds ELA Medical, Inc./ Sorin Group

Plymouth, MN

55441

Approval for Programmer Software Version Smartview 2.20UG1 for use with the Ovation and Paradym ICDs and CRT-Ds and the Reply and Esprit Pacemakers.
P060033/S046

6/11/10

135-Day

Endeavor Zotarolimus-Eluting Coronary Stent Systems Medtronic Vascular, Inc.

Santa Rosa, CA

95403

Approval for a change to remove the functional test from the Quality Release Specification.
P060033/S047

6/4/10

135-Day

Endeavor Zotarolimus-Eluting Coronary Stent Systems Medtronic Vascular, Inc.

Santa Rosa, CA

95403

Approval for a change to the balloon subassembly manufacturing process.
P060039/S010

6/30/01

180-Day

Attain StarFix Lead Medtronic, Inc.

Mounds View, MN

55112

Approval of the post-approval study protocol.
P070007/S018

6/18/10

180-Day

Talent Thoracic Stent Graft System Medtronic Vascular, Inc.

Santa Rosa, CA

95403

Approval for a sterilization site located at Isotron Ireland Ltd, Offaly, Ireland, as an alternative E-beam sterilization site.
P070009/S009

6/4/10

Special

Realize® Adjustable Gastric Band with Injection Port & Applier Ethicon Endo-Surgery, Inc.

Cincinnati, OH 45242

Approval for minor changes ot the labeling.
P070014/S007

6/11/10

180-Day

LifeStent and LifeStent XL Vascular Stent Systems Bard Peripheral Vascular, Inc.

Tempe, AZ

85280

Approval for a change in labeling that updates the Instructions for Use and the Patient Information Brochure to include the most recent clinical data up to 2 years.
P070014/S008

6/9/10

135-Day

Bard® LifeStent® Vascular Stent Systems Bard Peripheral Vascular

Tempe, AZ

85280

Approval for moving a manufacturing process and associated equipment from a supplier to internal manufacturing at BARD Angiomed GmbH & Co. Medizintchnik KG (Angiomed) for the delivery system tip chamfering manufacturing.
P070014/S009

6/11/10

135-Day

Bard® LifeStent® Vascular Stent Systems Bard Peripheral Vascular, Inc.

Tempe, AZ

85280

Approval for a second sterilization cycle.
P070027/S017

6/18/10

180-Day

Talent Occluder with Occluder Delivery System Medtronic Vascular

Santa Rosa, CA

95403

Approval for a manufacturing site located at Medtronic Ireland, Galway, Ireland, for final assembly processes and for Isotron Ireland, Ltd., Tullamore, Ireland, for sterilization services.
P070027/S018

6/18/10

180-Day

Talent Abdominal Stent Graft System Medtronic Vascular

Santa Rosa, CA

95403

Approval for a sterilization site located at Isotron Ireland Ltd, Offaly, Ireland, as an alternative E-beam sterilization site.
P080013/S001

6/29/10

180-Day

DuraSeal Xact Sealant System Confluent Surgical, Inc.

Waltham, MA

02451

Approval of the post-approval study protocol.
P090022/S001

6/17/10

Real-Time

Softec HD Posterior Chamber Intraocular Lens (IOL) Lenstec, Inc.

St. Petersburg, FL

33716

Approval for modifications to the optic design of the Softec HD lens to introduce bi-spheric optic surfaces and changes to the labeling related to the introduction of the modified lens. The device, as modified, will be marketed under the trade name Softec I and is indicated for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21. The lens is indicated for capsular bag replacement.
APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P810002/S071

6/30/10

St. Jude Mechanical Heart Valve St. Jude Medical

St. Paul, MN

55117

Elimination of a redundant in-process inspection step.
P810006/S033

6/22/10

CollaStat® Absorbable Collagen Sponge Hemostatic Agents Integra LifeSciences Corp.

Plainsboro, NJ

08536

Change in manufacturing equipment.
P810032/S056

6/1/10

Acrysof®, Acrysof® ReSTOR, and PMMA Intraocular Lenses Alcon Research, Ltd.

Ft. Worth, TX

76134

Change to the Lens Bench Alarm System.
P810032/S057

6/2/10

Acrysof® and PMMA Intraocular Lenses Alcon Research, Ltd.

Ft. Worth, TX

76134

Elimination of a quality control test during the manufacture of the device.
P840001/S151

6/17/10

Restore® Family of Implantable Neurostimulators Medtronic, Inc.

Minneapolis, MN

55432

Addition of an alternate supplier for the gold plating process.
P840001/S154

6/30/10

Spinal Cord Stimulation Systems Medtronic, Inc.

Minneapolis, MN

55432

Change to an in-line Automated Optical Inspection (AOI) and pressurized Nitrogen gas cleaning.
P840001/S155

6/23/10

RestoreUltra Medtronic Neuromodulation

Minneapolis, MN

55432

Replacement of the legacy electrical test stations at the feedthrough.
P840060/S033

6/1/10

Acrysof®, Acrysof® ReSTOR, and PMMA Intraocular Lenses Alcon Research, Ltd.

Ft. Worth, TX

76134

Change to the Lens Bench Alarm System.
P840060/S034

6/2/10

Acrysof® and PMMA Intraocular Lenses Alcon Research, Ltd.

Ft. Worth, TX

76134

Elimination of a quality control test during the manufacture of the device.
P840062/S020

6/22/10

CollaCote® Absorbable Collagen Wound Dressing for Dental Surgery and CollaTape® Absorbable Collagen Wound Dressing for Dental Surgery Integra LifeSciences Corp.

Plainsboro, NJ

08536

Change in manufacturing equipment.
P840064/S042

6/16/10

DISCOVISC®, VISCOAT® and DUOVISC® Alcon Research, Ltd.

Ft. Worth, TX

76134

Expansion of the use of a previously approved cleanroom for aseptic filling to include aseptic compounding.
P840064/S043

6/16/10

DISCOVISC®, VISCOAT®, AND DUOVISC® Alcon Research, Ltd.

Ft. Worth, TX

76134

Use of a newly constructed cleanroom for aseptic compounding and aseptic filling processes.
P850010/S030

6/22/10

HeliStat® Absorbable Collagen Hemostatic Agents Integra LifeSciences Corp.

Plainsboro, NJ

08536

Change in manufacturing equipment.
P860004/S131

6/24/10

Synchromed Infusion System Medtronic Neuromodulation

Minneapolis, MN

55432

Change to the distal end taper lengths of the Medtronic Intrathecal Catheters, Models 8709, 8709SC, and 8711.
P860004/S132

6/30/10

Synchromed Infusion System Medtronic, Inc.

Minneapolis, MN

55432

Change to an in-line Automated Optical Inspection (AOI) and pressurized Nitrogen gas cleaning.
P860019/S256

6/23/10

Maverick 2 Monorail & Maverick Over-the-Wire Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilation Catheters Boston Scientific Corporation

Maple Grove, MN

55311

Change to the post-swaged inspection method from a manual to an automated process.
P870076/S010

6/2/10

Falope-Ring Band and Applicator Systems Gyms ACM1, Inc.

Southborough, MA 01772

Change to the supplier of three components.
P880006/S066

6/18/10

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

Sylmar, CA

91432

Alternate method of bioburden testing.
P880086/S187

6/23/10

Affinity, Integrity, Victory Family of Pacemakers St. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91432

Alternate metallization of discrete components.
P880086/S188

6/18/10

Affinity/Integrity/ Victory Family of Pacemakers St. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91432

Alternate method of bioburden testing.
P880087/S015

6/1/10

Acrysof®, Acrysof® ReSTOR, and PMMA Intraocular Lenses Alcon Research, Ltd.

Ft. Worth, TX

76134

Change to the Lens Bench Alarm System.
P880087/S016

6/2/10

Acrysof® and PMMA Intraocular Lenses Alcon Research, Ltd.

Ft. Worth, TX

76134

Elimination of a quality control test during the manufacture of the device.
P890047/S030

6/16/10

DISCOVISC®, VISCOAT® and DUOVISC® Alcon Research, Ltd.

Ft. Worth, TX

76134

Expansion of the use of a previously approved cleanroom for aseptic filling to include aseptic compounding.
P890047/S031

6/16/10

PROVISC® Alcon Research, Ltd.

Ft. Worth, TX

76134

Use of a newly constructed cleanroom for aseptic compounding and aseptic filling processes.
P900056/S100

6/23/10

Rotablator™ Rotational Angioplasty System Boston Scientific Corporation

Maple Grove, MN

55311

Change to component materials.
P910023/S234

6/23/10

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

Sylmar, CA

91432

Alternate metallization of discrete components.
P910023/S235

6/18/10

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

Sylmar, CA

91432

Alternate method of bioburden testing.
P920047/S042

6/30/10

Blazer Prime HTD Catheter Boston Scientific Corporation

San Jose, CA

95134

Addition of a 70% Isopropyl Alcohol wipe in the manufacturing process.
P930014/S040

6/1/10

Acrysof®, Acrysof® ReSTOR, and PMMA Intraocular Lenses Alcon Research, Ltd.

Ft. Worth, TX

76134

Change to the Lens Bench Alarm System.
P930014/S041

6/2/10

Acrysof® and PMMA Intraocular Lenses Alcon Research, Ltd.

Ft. Worth, TX

76134

Elimination of a quality control test during the manufacture of the device.
P960009/S081

6/17/10

Activa® Implantable Neurostimulators Medtronic, Inc.

Minneapolis, MN

55432

Addition of an alternate supplier for the gold plating process.
P960009/S084

6/30/10

Activa Deep Brain Stimulation (DBS) Medtronic, Inc.

Minneapolis, MN

55432

Change to an in-line Automated Optical Inspection (AOI) and pressurized Nitrogen gas cleaning.
P960009/S085

6/23/10

Activa RC Medtronic Neuromodulation

Minneapolis, MN

55432

Replacement of the legacy electrical test stations at the feedthrough.
P960013/S060

6/10/10

Tendril STS Leads St. Jude Medical, CRMD

Sylmar, CA

91342

Alternate vendor for the soft tip component.
P960022/S006

6/16/10

Bausch & Lomb® SofLens Toric® and SofLens66® (alphafilcon A) Bausch & Lomb

Rochester, NY

14609

Addition of a new supplier of crosslinking material.
P970004/S086

6/30/10

Interstim Therapy for Urinary Control Medtronic, Inc.

Minneapolis, MN

55432

Change to an in-line Automated Optical Inspection (AOI) and pressurized Nitrogen gas cleaning.
P970012/S067

6/2/10

Kappa 400 DR and Kappa 400 SR IPGs Medtronic, Inc.

Mounds View, MN

55112

Relocation of an ethylene oxide sterilizer.
P970013/S033

6/18/10

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

Sylmar, CA

91432

Alternate method of bioburden testing.
P970055/S009

6/10/10

Parvovirus B19 IgM Enzyme Immunoassay Biotrin International, Ltd.

Dublin, Ireland

Procedure change for a component.
P980016/S238

6/2/10

GEM II, Marquis, Maximo, Intrinsic, EnTrust, Virtuoso, Maximo II DR/VR, Virtuoso II DR/VR, and Secura DR/VR Family of ICDs Medtronic, Inc.

Mounds View, MN

55112

Relocation of an ethylene oxide sterilizer.
P980016/S239

6/3/10

Secura DR/VR, Maximo II DR/VR, Virtuoso II DR/VR Family of ICDs Medtronic, Inc.

Mounds View, MN

55112

Change in location for a supplier of Zener diodes.
P980016/S243

6/23/10

Secura VR, Maximo II VR, Virtuoso II VR Family of ICDs Medtronic, Inc.

Mounds View, MN

55112

Change to the ICCD test limits.
P980016/S244

6/30/10

Secura DR/VR, Maximo II DR/VR, Virtuoso II DR/VR Family of ICDs Medtronic, Inc.

Mounds View, MN

55112

Changes related to hybrid cleaning and inspection process.
P980022/S072

6/10/10

MMT-7002 & MMT07003 Glucose Sensors Medtronic MiniMed

Northridge, CA

91325

Change to glucose sensors and the addition of a new vendor.
P980035/S167

6/2/10

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

Mounds View, MN

55112

Relocation of an ethylene oxide sterilizer.
P980035/S170

6/25/10

Sigma, 350 Series, AT500, and EnRhythm IPGs Medtronic, Inc.

Mounds View, MN

55112

Replacement of the legacy electrical test station.
P980035/S171

6/30/10

Adapta, Sensia, Versa, Relia, and EnRhythm IPGs Medtronic, Inc.

Mounds View, MN

55112

Changes related to hybrid cleaning and inspection process.
P990001/S067

6/2/10

Clarity DDDR, Clarity SSIR, Diamond III, Ruby III, Topaz III, Jade

III, Vita 2 DDDR, C-Series, and T-Series Family of IPGs

Medtronic, Inc.

Mounds View, MN

55112

Relocation of an ethylene oxide sterilizer.
P990001/S070

6/25/10

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

Mounds View, MN

55112

Replacement of the legacy electrical test station.
P990023/S009

6/16/10

CELLUGEL® Alcon Research, Ltd.

Ft. Worth, TX

76134

Use of a newly constructed cleanroom for aseptic compounding and aseptic filling processes.
P990040/S011

6/9/10

TRUFILL® n-Butyl Cyanoacrylate

(N-BCA) Liquid Embolic System

Codman & Shurtleff, Inc.

Raynham, MA

02989

Transfer the supplier of the tantalum powder and elimination of redundant elemental analysis and redundant tantalum particle size testing.
P000027/S008

6/8/10

Elecsys Free PSA Calcheck Roche Diagnostics

Indianapolis, IN

46250

Change in manufacturing site for final packaging and labeling of the device.
P010013/S028

6/1/10

NovaSure® Impedance Controlled Endometrial Ablation System Hologic, Inc.

Marlborough, Massachusetts 01752

Replace a manual tube cutting step with an automated method.
P010013/S029

6/23/10

NovaSure® Impedance Controlled Endometrial Ablation System Hologic, Inc.

Marlborough, MA

01752

Change in the method of measuring the dimensions of two components of the NovaSure System.
P010015/S085

6/2/10

InSync and InSync III Family of CRT-Ps Medtronic, Inc.

Mounds View, MN

55112

Relocation of an ethylene oxide sterilizer.
P010015/S088

6/25/10

InSync III IPGs Medtronic, Inc.

Mounds View, MN

55112

Replacement of the legacy electrical test station.
P010015/S089

6/30/10

InSync III CRT-P Medtronic, Inc.

Mounds View, MN

55112

Changes related to hybrid cleaning and inspection process.
P010019/S015

6/4/10

Lotrafilcon Soft Contact Lenses for Extended Wear CIBA Vision Corporation

Duluth, GA

30097

Change to the use of an automated vision inspection system.
P010030/S020

6/9/10

LifeVest Wearable Cardioverter Defibrillator ZOLL Lifecor Corp.

Pittsburgh, PA

15238

Minor test modification to an electrode belt functional test.
P010031/S196

6/2/10

InSync,

InSync Marquis, InSync II Marquis, InSync III Marquis,

InSync II Protect, InSync Sentry, and InSync Maximo Family of

ICDs; Concerto, Concerto II, Maximo II, and Consulta Family of

CRT-Ds

Medtronic, Inc.

Mounds View, MN

55112

Relocation of an ethylene oxide sterilizer.
P010031/S197

6/3/10

Concerto II, Consulta, Maximo II Family of CRT-Ds Medtronic, Inc.

Mounds View, MN

55112

Change in location for a supplier of Zener diodes.
P010031/S201

6/30/10

Consulta CRT-D, Consulta II CRT-D, Maximo II CRT-D, InSync Maximo ICD, and InSync Sentry ICD Medtronic, Inc.

Mounds View, MN

55112

Changes related to hybrid cleaning and inspection process.
P010054/S012

6/4/10

Elecsys Anti-HBs CalCheck Roche Diagnostics

Indianapolis, IN

46250

Change in manufacturing site for packaging and labeling of the device.
P020009/S064

6/23/10

Express 2 Stent Delivery System Boston Scientific

Maple Grove, MN

55311

Fixture change in the Heat Set equipment.
P020025/S023

6/30/10

Blazer Prime XP Catheter Boston Scientific Corporation

San Jose, CA

95134

Addition of a 70% Isopropyl Alcohol wipe in the manufacturing process.
P020047/S020

6/23/10

Multi-Link Mini Vision® Coronary Stent Systems Abbott Vascular

Temecula, CA 92590

Optimization of the laser power setting used for soft tip attach.
P030017/S104

6/3/10

Precision Spinal Cord Stimulator (SCS) System Boston Scientific Neuromodulation Corporation

Valencia, CA

91355

Addition of a rework process for the distal end of the Short Tip (ST) Linear Lead.
P030017/S106

6/23/10

Precision Spinal Cord Stimulator (SCS) System Boston Scientific Neuromodulation Corporation

Valencia, CA

91355

Change in the assembly of the Charger 2.0 Printed Circuit Board (PCB) at the current supplier.
P030022/S014

6/11/10

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

Memphis, TN

38116

Change in the HA Coating vendor.
P030035/S068

6/23/10

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

Sylmar, CA

91432

Alternate metallization of discrete components.
P030035/S069

6/18/10

Frontier/Frontier II Family of CRT-Ps St. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91432

Alternate method of bioburden testing.
P030054/S151

6/23/10

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

Sylmar, CA

91432

Alternate metallization of discrete components.
P030054/S152

6/18/10

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

Sylmar, CA

91432

Alternate method of bioburden testing.
P040016/S058

6/23/10

VeriFLEX (Liberté®) Coronary Stent System Boston Scientific

Maple Grove, MN

55311

Fixture change in the Heat Set equipment.
P040020/S024

6/1/10

Acrysof®, Acrysof® ReSTOR, and PMMA Intraocular Lenses Alcon Research, Ltd.

Ft. Worth, TX

76134

Change to the Lens Bench Alarm System.
P040020/S025

6/2/10

Acrysof® and PMMA Intraocular Lenses Alcon Research, Ltd.

Ft. Worth, TX

76134

Elimination of a quality control test during the manufacture of the device.
P040037/S026

6/23/10

Gore VIABAHN® Endoprosthesis W.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Alternate method for applying heparin coating.
P040047/S017

6/16/10

Coaptite® Injectable Implant BioForm Medical, Inc.

Franksville, WI

53126

Addition of two new clean room suites.
P050007/S026

6/3/10

StarClose SE® Vascular Closure System Abbott Vascular, Inc.

Redwood City, CA

94063

Increase in adhesive dispensing time.
P050012/S024

6/9/10

DexCom™ Seven® Plus System DEXCOM, Inc.

San Diego, CA

92121

Change to improve the manufacturing consistency of the sensor component of the Seven® and the Seven® Plus Continuous Glucose Monitoring System.
P060001/S009

6/18/10

PROTÉGÉ GPS and RX Carotid Stent Systems ev3, Inc.

Plymouth, MN

55441

Modification to the molded tip raw material.
P060008/S054

6/18/10

TAXUS® Liberté Paclitaxel-Eluting Coronary Stent System Boston Scientific

Maple Grove, MN

55311

Changes to the Drug Assay and Content Uniformity method, and the Drug Impurities and degradation method.
P060008/S055

6/23/10

TAXUS® Liberté Paclitaxel-Eluting Coronary Stent System Boston Scientific

Maple Grove, MN

55311

Fixture change in the Heat Set equipment.
P060012/S002

6/3/10

AxSYM Core 2.0 Abbott Laboratories

Diagnostics Division

Abbott Park, IL 60064

Change to the matching test procedure to allow optimization of

microparticle percent solids based on a target index calibrator signal rate count.

P060030/S010

6/15/10

COBAS AmpliPrep/ COBAS TaqMan HCV Test Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Change to the manufacture of bulk Magnetic Glass Particles to allow use of a second sintering oven.
P060033/S052

6/23/10

Endeavor Zotarolimus-Eluting Coronary Stent Systems and Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems Medtronic Vascular

Santa Rosa, CA

95403

Change to a component manufacturing process.
P060033/S055

6/30/10

Endeavor Zotarolimus-Eluting Coronary Stent Systems and Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems Medtronic Vascular

Santa Rosa, CA

95403

Change to manufacturing process equipment.
P070001/S006

6/25/10

ProDisc C Synthes Spine

West Chester, PA 19380

Change in the HA Coating Vendor.
P070014/S015

6/23/10

Bard® LifeStent® Vascular Stent Systems Bard Peripheral Vascular, Inc.

Tempe, AZ

85280

New manufacturing aid.
P070014/S016

6/23/10

Bard® LifeStent® Vascular Stent Systems Bard Peripheral Vascular, Inc.

Tempe, AZ

85280

Change in raw material supplier for the manufacturing of a component of the delivery catheter.
P070014/S017

6/23/10

Bard® LifeStent® Vascular Stent Systems Bard Peripheral Vascular, Inc.

Tempe, AZ

85280

Addition of alternate tensile testing equipment as part of the package peel testing procedures.
P070015/S037

6/11/10

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

Temecula, CA

92591

Extending the retest period for the everolimus drug.
P080006/S008

6/16/10

Attain Ability Lead Medtronic, Inc.

Mounds View, MN

55112

Transfer of Medtronic’s Rice Creek silicone molding operations.
P080014/S002

6/28/10

Cervista® HPV HR Hologic, Inc.

Marlborough, MA

01752

New supplier of Bovine Serum Albumin (BSA), a raw material used in the production of one component of the device.
P080015/S001

6/28/10

Cervista® HPV 16/18 Hologic, Inc.

Marlborough, MA

01752

New supplier of Bovine Serum Albumin (BSA), a raw material used in the production of one component of the device.
P090003/S002

6/11/10

Express™ LD Iliac Premounted Stent System Boston Scientific

Maple Grove, MN

55311

Modification to the balloon wing-folding machine.

Summary of PMA Originals & Supplements Approved

Originals: 2

Supplements: 75

Summary of PMA Originals Under Review

Total Under Review: 83

Total Active: 38

Total On Hold: 45

Number Greater Than 180 Days: 6

Summary of PMA Supplements Under Review

Total Under Review: 608

Total Active: 410

Total On Hold: 198

Number Greater Than 180 Days: 16

Summary of All PMA Submissions Received

Originals: 6

Supplements: 76

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 75

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 213.4

FDA Time: 98.4 Days MFR Time: 115 Days

    

SOURCE

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