P030005

1/26/04

CONTAK® RENEWAL™ Models H125 and H120 with the Model 2865 Version 1.8 Application Software

Guidant Corporation

St. Paul, MN

55112

Approval for the CONTAK RENEWAL TR.  The device is indicated s follows:  The CONTAK RENEWAL TR pulse generator is indicated for patients who have moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF < 35%) and QRS duration > 120 ms and remain symptomatic despite stable, optimal heart failure drug therapy (as defined in the clinical trials section).  The device provides atrial-ventricular tracking modes to help preserve AV synchrony, and adaptive-rate pacing for patients who would benefit from adjusted pacing rates concurrent with physical activity.

P820088/S017

1/20/04

180-Day

BSD-500 Hyperthermia System

BSD Medical Corporation

Salt Lake City, UT

84119

Approval to replace the generator approved in PMA P820088/S005.  The device, as modified, will be marketed under the same trade name, BSD-500 Hyperthermia System and is indicated for treatment of solid malignant tumors by localized heat delivery.

P830045/S090

1/30/04

Real-Time

Verity ADx XL VDR Model 5456i

St. Jude Medical

Sylmar, CA

91342

Approval to modify the header design of a currently marketed device.  The device, as modified, will be marketed under the trade name Verity ADx XL VDR Model 5456i and is indicated as follows:  The Verity ADx XL VDR Model 5456i is indicated for use only with AV Plus Model 1328C or 1358C single-pass in-line quadripolar leads (the Verity ADx XL VDR Pacing System).  The Verity ADx XL VDR Pacing System is intended to provide VDD or VDDR pacing for patients with a healthy sinus node and AV conduction abnormalities.  These modes are indicated for patients who need ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present.  This includes the presence of complete AV block when:  a) atrial contribution is needed for hemodynamic benefit, and  b) pacemaker syndrome had existed or is anticipated.  Additional indications include normal sinus rhythm and normal AV conduction in patients who intermittently need ventricular pacing.

P840001/S069

1/6/04

180-Day

Intrel® 3, Synergy ™ and Synergy Versitrel™ neurostimulators

Medtronic Neurological

Minneapolis, MN

55432

Approval for a revised labeling architecture.

P850022/S015

1/12/04

180-Day

Bioelectron SpinalPak II Spine  Fusion Stimulator

EBI, L.P.

Parcippany, NJ

07054

Approval for a modified version of the Bioelectron SpinalPak Fusion Stimulator.  The modifications are:  1) The current SpinalPak is powered by 1 Alkaline 9 volt battery that must be replaced daily.  The modified version will be powered by 1 NiMN “AA” rechargeable cell.  The charger will be included.  2) The housing has been modified to accommodate for a rechargeable battery and an LCD display.  The current SpinalPak has an LED display.  The modified version will have a 6 message LCD display.  3) The PCB circuitry has been modified to accommodate the LCD display and the rechargeable battery pack.  4) The original software was written in Assembly Code.  The modified version was rewritten in C.  The device, as modified, will be marketed under the trade name Bioelectron SpinalPak II Spine Fusion Stimulator and is indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.

P860057/S022

1/26/04

180-Day

Carpentier-Edwards® Perimount® Pericardial Bioprosthesis, Models 2700, 2800 (Perimount® RSR), 6900P (Perimount Plus®), and 3000 (Perimount Magna®)

Edwards Lifesciences LLC

Irvine, CA

92614

Approval for the addition of a post-fixation tissue heat treatment step solution prior to the Edwards XenoLogiX® tissue valve processing steps.  The devices, as modified, will be marketed with the reference to ThermaFix™ as the trademark/brand name for the tissue processing method and will be identified according to the following modified model numbers: Models 2700 TFX, 2800TFX, 6900TFX, and 3000TFX.

P880086/S098

1/30/04

Real-Time

Verity ADx XL VDR Model 5456i

St. Jude Medical

Sylmar, CA

91342

Approval to modify the header design of a currently marketed device.  The device, as modified, will be marketed under the trade name Verity ADx XL VDR Model 5456i and is indicated as follows:  The Verity ADx XL VDR Model 5456i is indicated for use only with AV Plus Model 1328C or 1358C single-pass in-line quadripolar leads (the Verity ADx XL VDR Pacing System).  The Verity ADx XL VDR Pacing System is intended to provide VDD or VDDR pacing for patients with a healthy sinus node and AV conduction abnormalities.  These modes are indicated for patients who need ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present.  This includes the presence of complete AV block when:  a) atrial contribution is needed for hemodynamic benefit, and  b) pacemaker syndrome had existed or is anticipated.  Additional indications include normal sinus rhythm and normal AV conduction in patients who intermittently need ventricular pacing.

P890023/S014

1/14/04

180-Day

Hydrogenics 60 (ocufilcon F) UV IMT Soft (Hydrophilic) Contact Lens

Ocular Sciences, Inc.

Hampshire, UK

S053 4ND

Approval for manufacturing sites located at Ocular Sciences Puerto Rico in Juana Diaz, Puerto Rico and Santa Isabel, Puerto Rico.

P900056/S079

1/8/04

180-Day

Rotablator™ Rotational Angioplasty System

Boston Scientific Corporation

Maple Grove, MN

55311

Approval for a manufacturing site for the console and associated accessories located at Plexus EA Seattle, Bothell, Washington.

P950002/S013

1/29/04

Real-Time

VISTA™ Lordotic Interbody Fusion Cage

Centerpulse Spine-Tech, Inc.

Minneapolis, MN

55439

Approval for the VISTA™ Lordotic device to the approved product line for the BAK Interbody Fusion System.  The device will be marketed under the trade name VISTA™ Lordotic and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two continuous levels from L4-L5 and/or L5-S1.  These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).  DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.  These patients should be skeletally mature and have had six months of non-operative treatment.  VISTA™ Lordotic devices are to be implanted via an open anterior approach.

P970004/S027

1/28/04

Special

Medtronic InterStim® Therapy for Urinary Control

Medtronic Gastroenterology/ Urology (MGU)

Shoreview, MN

55126

Approval for a change in the technical manual to provide physicians with instructions on removal of the tined lead.

P980012/S005

1/2/04

180-Day

Novacor N100PCq LVAS

World Heart, Inc.

Oakland, CA

94621

Approval for several specific engineering enhancements to the implanted (Pump/Drive Unit, Blood Conduits, and Percutaneous Lead) components of the Novacor N100PC LVAS system as well as modifications to the software to upgrade to the N100PCq LVAS system.  The device, as modified, will be marketed under the trade name Novacor N100PCq LVAS system and is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular function for use both inside and outside the hospital.

P980022/S010

1/7/04

Panel

Guardian Telemetered Glucose Monitoring System (TGMS)

Medtronic MiniMed

Northridge, CA

91325

Approval for the Guardian Telemetered Glucose Monitoring System (TGMS).  The device is indicated for continuous or periodic monitoring of interstitial glucose values in persons with diabetes mellitus.  Glucose values calculated by the device will be used to trigger hypo- and hyperglycemia alerts but glucose values will not be displayed.  Up to 21 days of stored data can be downloaded to a personal computer to identify patterns and optimize diabetes management.

P980041/S004

1/20/04

180-Day

Access® AFP Reagents on the Access® Immunoassay Analyzer

Beckman Coulter, Inc.

Chaska, MN

55318

Approval for a manufacturing site located at Beckman Coulter, Inc., Chaska, Minnesota.

P980043/S004

1/23/04

Special

Medtronic HANCOCK® II Bioprosthesis Models T505, T510

Medtronic Heart Valves

Santa Ana, CA

92705

Approval for a modification to the Instructions for Use.

P990020/S015

1/30/04

180-Day

AneuRx Stent Graft System with Xpedient Delivery System

Medtronic Vascular

Santa Rosa, CA

95403

Approval for use of a High-Density Graft Material (HDM) in the manufacture of the AneuRx Stent Graft.

P990064/S009

1/23/04

Special

Medtronic MOSAIC® Porcine Bioprosthesis Models 305, 310

Medtronic Heart Valves

Santa Ana, CA

92705

Approval for a modification to the Instructions for Use.

P990075/S014

1/16/04

180-Day

Saline-Filled Mammary Prosthesis and Spectrum® Post-Operatively Adjustable Saline-Filled Mammary Prosthesis

Mentor Corporation

Santa Barbara, CA

93111

Approval for revised labeling that reflects 7-year post-approval study data.

P000023/S003

1/22/04

180-Day

TMJ Fossa Eminence Prosthesis

TMJ Implants, Inc.

Golden, CO

80401

Approval for a new manufacturing site for the CrystalClear Anatomical Model.  The site is located at TMJ Implants, Inc., Golden, Colorado.

P000035/S003

1/22/04

180-Day

TMJ Fossa Eminence/Condylar Prosthesis System

TMJ Implants, Inc.

Golden, CO

80401

Approval for a new manufacturing site for the CrystalClear Anatomical Model.  The site is located at TMJ Implants, Inc., Golden, Colorado.

P010018/S006

1/15/04

180-Day

Viewpoint CK System

Refractec, Inc.

Irvine, CA

92618

Approval for an alternate manufacturing site for the sub-assembly of the RCS-300 console component at Stellartech Research Corp., Sunnyvale, California.

P010032/S009

1/20/04

Real-Time

Genesis Neurostimulation (IPG) System

Advanced Neuromodulation Systems, Inc.

Plano, TX

75024

Approval for the use of the Axxess Percutaneous Lead Models 4143, 4146, 4153 and 4156 with the ANS Genesis Neurostimulation (IPG) Model 3608, the ANS Genesis XP Neurostimulation (IPG) Model 3609, the ANS Genesis Dual XP Neurostimulation (IPG) Model 3644 and the ANS genesis G4 Neurostimulation (IPG) Model 3604 which are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

P010068/S002

1/14/04

Real-Time

QwikStar DS Diagnostic/Ablation Catheter

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for modifications mad to the NaviStar DS 8mm Tip Deflectable Diagnostic/Ablation Catheter approved under P010068 and the QwikStar™ 4 mm Deflectable Tip Diagnostic/Ablation Catheter approved under P990025/S004.  The device, as modified, will be marketed under the trade name QwikStar™ DS Diagnostic/Ablation Catheter and is indicated for catheter based cardiac electrophysiological mapping (stimulation and recording) and when used with the Stockert 70 RF generator (software version 1.033 or higher) for the treatment of Type I atrial flutter in patients 18 years or older.

P030039/S001

1/12/04

180-Day

Coseal Surgical Sealant

Baxter Healthcare Corporation

Fremont, CA

94555

Approval for a manufacturing site located at Baxter Healthcare Corporation, Baxter Biosciences, Division, Fremont, California.

P860019/S199

1/7/04

PTCA/Perfusion Catheters

Boston Scientific Corporation

Maple Grove, MN

55311

Change in the manufacturing process which involved the use of an alternate Biological Indicator (BI) with a shorter labeled incubation time for use in monitoring the EO sterilization cycles and sterilization process validation.

P880027/S063

1/7/04

PTCA Catheters

Boston Scientific Corporation

Maple Grove, MN

55311

Change in the manufacturing process which involved the use of an alternate Biological Indicator (BI) with a shorter labeled incubation time for use in monitoring the EO sterilization cycles and sterilization process validation.

P880065/S009

1/7/04

Aortic Valvuloplasty Balloon Dilitation Catheter

Boston Scientific Corporation

Maple Grove, MN

55311

Change in the manufacturing process which involved the use of an alternate Biological Indicator (BI) with a shorter labeled incubation time for use in monitoring the EO sterilization cycles and sterilization process validation.

P900056/S080

1/7/04

Rotablator Rotational Angioplasty System Wire

Boston Scientific Corporation

Maple Grove, MN

55311

Change in the manufacturing process which involved the use of an alternate Biological Indicator (BI) with a shorter labeled incubation time for use in monitoring the EO sterilization cycles and sterilization process validation.

P920047/S022

1/7/04

EPT-1000 Cardiac Ablation Systems

Boston Scientific Corporation

Maple Grove, MN

55311

Change in the manufacturing process which involved the use of an alternate Biological Indicator (BI) with a shorter labeled incubation time for use in monitoring the EO sterilization cycles and sterilization process validation.

P930031/S020

1/7/04

Wallstent Tips Endoprosthesis

Boston Scientific Corporation

Maple Grove, MN

55311

Change in the manufacturing process which involved the use of an alternate Biological Indicator (BI) with a shorter labeled incubation time for use in monitoring the EO sterilization cycles and sterilization process validation.

P940019/S017

1/7/04

Wallstent Iliac Endoprosthesis

Boston Scientific Corporation

Maple Grove, MN

55311

Change in the manufacturing process which involved the use of an alternate Biological Indicator (BI) with a shorter labeled incubation time for use in monitoring the EO sterilization cycles and sterilization process validation.

P950020/S009

1/7/04

Cutting Balloon

Boston Scientific Corporation

Maple Grove, MN

55311

Change in the manufacturing process which involved the use of an alternate Biological Indicator (BI) with a shorter labeled incubation time for use in monitoring the EO sterilization cycles and sterilization process validation.

P950032/S037

1/23/04

Apligraf™

Organogenisis, Inc.

Canton, MA

02021

Two manufacturing changes involving the seed pool production process.

P970061/S020

1/7/04

Radius™ Coronary Stent with Delivery System

Boston Scientific Corporation

Maple Grove, MN

55311

Change in the manufacturing process which involved the use of an alternate Biological Indicator (BI) with a shorter labeled incubation time for use in monitoring the EO sterilization cycles and sterilization process validation.

P980003/S011

1/7/04

Chilli Cooled Ablation Systems

Boston Scientific Corporation

Maple Grove, MN

55311

Change in the manufacturing process which involved the use of an alternate Biological Indicator (BI) with a shorter labeled incubation time for use in monitoring the EO sterilization cycles and sterilization process validation.

P980033/S009

1/7/04

Wallstent Venous Endoprosthesis

Boston Scientific Corporation

Maple Grove, MN

55311

Change in the manufacturing process which involved the use of an alternate Biological Indicator (BI) with a shorter labeled incubation time for use in monitoring the EO sterilization cycles and sterilization process validation.

P990054/S007

1/7/04

Chilli Cooled Ablation Systems

Boston Scientific Corporation

Maple Grove, MN

55311

Change in the manufacturing process which involved the use of an alternate Biological Indicator (BI) with a shorter labeled incubation time for use in monitoring the EO sterilization cycles and sterilization process validation.

P000029/S005

1/13/04

Deflux Injectable Gel

Q-Med Scandinavia, Inc.

Herndon, VA

20171

Change in the visual inspection process to employ a new semi-automatic inspection machine.

P020009/S014

1/7/04

Express Coronary Stent System

Boston Scientific Corporation

Maple Grove, MN

55311

Change in the manufacturing process which involved the use of an alternate Biological Indicator (BI) with a shorter labeled incubation time for use in monitoring the EO sterilization cycles and sterilization process validation.

P020025/S003

1/7/04

EPT-1000 XP RF Ablation Systems

Boston Scientific Corporation

Maple Grove, MN

55311

Change in the manufacturing process which involved the use of an alternate Biological Indicator (BI) with a shorter labeled incubation time for use in monitoring the EO sterilization cycles and sterilization process validation.