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PMA Final Decisions Rendered for December 2002

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME
CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P010055

12/23/02

ProstaLund® CoreTherm™ System Microwave Thermotherapy for BPH

ProstaLund Operations AB

Lund, Sweden

SE-226 60

Approval for the ProstaLund® CoreTherm™ Microwave Thermotherapy System.  The ProstaLund® CoreTherm™ is a non-surgical, minimally invasive device intended to relieve symptoms associated with symptomatic Benign Prostatic Hyperplasia (BPH) by ProstaLund® Feedback Treatment® (PLFT®), and is indicated for men with prostate size of 30 to 100g and prostatic urethra length ≥ 35 mm.

P020007

12/18/02

Medtronic AVE Bridge™ Extra Support Over-the-Wire (OTW) Renal Stent System

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Approval for the Medtronic AVE Bridge™ Extra Support Over-the-Wire (OTW) Renal Stent System.  The device is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal or failed percutaneous transluminal renal angioplasty (PTRA) of a de novo lesion (≤15 mm in length) located within 10 mm of the aortorenal border and with a reference vessel diameter of 5.0 to 7.0 mm.  Sub-optimal or failed PTRA include any of the following:  visible evidence of a residual stenosis ≥50% after optimal PTRA, visible evidence of intimal dissection >6 mm, or peak systolic trans-stenotic gradient of ≥20 mm Hg or a mean of ≥10 mm Hg.

P020008

12/12/02

Karl Storz Autofluorescence System (D-light AF, Flexible PDD Bronchoscope, Fluid Light Cables and Telecam®/Tricam® SL PDD).

Karl Storz Endoscopy-America

Culver City, CA

90230

Approval for the Karl Storz Autofluorescence System.  The Karl Storz Autofluorescence system is indicated for use in white light and autofluorescence bronchoscopy to identify and locate abnormal bronchial tissue for biopsy and histological evaluation.  It is indicated in patients who:  1) are suspected of having bronchogenic carcinoma and are scheduled for a bronchoscopy as part of a standard diagnostic staging or work-up  2) have been previously diagnosed with lung cancer and who are at high risk for recurrence  3) have abnormal sputum cytology  4) have abnormal chest X-ray, CT scan or similar technology.

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME
CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P810025/S021

12/03/02

180-Day

Amvisc® and Amvisc® Plus Sodium Hyaluronate Viscoelastics

Bausch & Lomb

San Dimas, CA

91773

Approval for a buffered formulation (pH 6.8 – 7.6) for Amvisc® and Amvisc® Plus Sodium Hyaluronate Viscoelastics.

P830055/S083

12/17/02

Real-Time

LCS Total Knee System

DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for the addition of thicker polyethylene tibial bearing components for the Sigma RP Stabilized polyethylene bearing components of the LCS Total Knee System.

P840024/S084

12/9/02

180-Day

Nucleus 22 Cochlear Implant System for Adults

Cochlear America

Englewood, CO

80112

Approval for expansion of the manufacturing facility located at Cochlear Limited, Lane Cove, Australia.

P840024/S086

12/27/02

180-Day

Nucleus 22 Cochlear Implant System for Adults

Cochlear America

Englewood, CO

80112

Approval for modification of the coil/cable of the ESPrit 3G Speech Processor to enable Nucleus 22 users to access the technological benefits of the ESPrit 3G.

P850035/S029

12/6/02

180-Day

Model SpF-60 Spinal Fusion Stimulator

EBI, L.P.

Parsippany, NJ

07054

Approval for the Model SpF-60 Implantable Spinal Fusion Stimulator and is indicated for use as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

P860004/S055

12/17/02

Real-Time

Medtronic SynchroMed Application Software for Model 8870, Medtronic Infusion Pump System

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the following two changes to the 8870 SynchroMed Application Software, approved as P860004/S052, for use with the N’Vision Programming System contained on Model 8870 Application Card.  The specific changes are:  1) A change to the 8870 SynchroMed Application Protocol Driver to ensure synchronization and  2) a microprocessor-reset feature to the Therapy Stop function to reset the stack pointer.

P860019/S192

12/17/02

Real-Time

Boston Scientific/Scimed NC BIG RANGER™ PTCA Catheter

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

 Approval to modify the labeling to extend the balloon compliance chart diameters to hundredths and to add a note to the Directions for Use stating the recommended minimum guide catheter lumen inner diameter.

P870072/S024

12/31/02

Special

Thoratec Ventricular Assist Device (VAD) System

Thoratec Corporation

Pleasanton, CA

94588

Approval for the addition of a warning statement to the package labels and to the Instructions for Use for the Beveled-Tip Atrial Cannula, as used with the Thoratec Ventricular Assist Device (VAD) System.

P880013/S009

12/17/02

180-Day

Nellcor Puritan Bennett Infant Star High Frequency Ventilator

Nellcor Puritan Bennett

Carlsbad, CA

92008

Approval for an additional manufacturing facility located at Nellcor Puritan Bennett, Inc., Minneapolis, Minnesota.

P880098/S012

12/10/02

Real-Time

Menicon SF-P™ (tisilfocon A) Rigid Gas Permeable Contact Lens

Menicon Co., Ltd.

Wilmington, MA

01887

Approval for Alcon® Unique-pH Multi-Purpose Solution as an alternate wet shipping solution for the Menicon SF-P™ Rigid Gas Permeable Contact Lens, labeling changes to reflect the use of Alcon® Unique-pH as a packaging solution and to update the labeling in accordance with recently approved Menicon Rigid Gas Permeable Contact Lens labeling.

P890027/S053

12/9/02

180-Day

Nucleus 22 Cochlear Implant for Children

Cochlear America

Englewood, CO

80112

Approval for expansion of the manufacturing facility located at Cochlear Limited, Lane Cove, Australia.

P890027/S055

12/27/02

180-Day

Nucleus 22 Cochlear Implant for Children

Cochlear America

Englewood, CO

80112

Approval for modification of the coil/cable of the ESPrit 3G Speech Processor to enable Nucleus 22 users to access the technological benefits of the ESPrit 3G.

P900052/S012

12/17/02

Real-Time

PORT-A-CATH® Epidural Implantable Access System, PORT-A-CATH® Epidural Low Profile™ Implantable Access System

Deltec, Inc.

St. Paul, MN

55112

Approval for:  1) the addition of procedural accessories to the PORT-A-CATH Epidural System kit, 2) an  alternate packaging configuration and  3) change in ethylene oxide residual limits.  These added accessories are exactly the same as those described in P900052/S005 for PORT-A-CATH II Epidural Low-Profile System.  The device, as modified, will be marketed under the trade name PORT-A-CATH® Epidural Low Profile™ Implantable Access System and PORT-A-CATH Epidural System kits.

P900060/S024

12/10/02

180-Day

Carbomedics Carbo-Seal Valsalva™ Ascending Aortic Prosthesis, Model CP-(size)

Sulzer Carbomedics, Inc.

Austin, TX

78752

Approval to combine the CarboMedics® Prosthetic Heart Valve (CPHV; approved on September 29, 1993 under P900060) with the Sulzer Vascutek® Gelweave Valsalva™ Vascular Prosthesis (cleared on June 13, 2002 under K013022).  The device, as modified, will be marketed under the trade name Carbomedics Carbo-Seal Valsalva™ Ascending Aortic Prosthesis, Model CP-(size), will be available in sizes 21, 23, 25, 27, 29, 31, and 33 mm, and is indicated for use in open heart surgery for simultaneous replacement of the ascending aorta and the aortic valve in cases of aneurysm, dissection, or other disease conditions of the aorta combined with disease or degeneration of the aortic valve.

P900066/S006

12/10/02

135-Day

Perfluoropropane for Pneumatic Retinopexy

Scott Medical Products

Plumsteadville, PA

18949

Approval to add a molecular sieve scrubbing step at the end of the gas manufacturing process.

P910071/S006

12/23/02

180-Day

ADATO® SIL-OL 5000 Silicone Oil Syringe

Bausch & Lomb, Inc.

San Dimas, CA

91773

Approval for the following changes for ADATO® SIL-OL 5000 Silicone Oil:  1) Addition of  a new primary container closure system (glass syringe);  2) Pharm Pur GmbH, Augsburg, Germany, as the site for filling, sterilization, labeling and packaging for ADATO® SIL-OL 5000 Silicone Oil packaged in a syringe;  3) Parametric release of the ADATO® SIL-OL 5000 Silicone Oil Syringe packaged product in lieu of end product sterility testing; and  4)  Double pouch packaging for ADATO® SIL-OL 5000 Silicone Oil Syringe.

P930029/S018

12/17/02

Real-Time

Medtronic Model 4819 Ablation Catheter to EP Recording System Cable

Medtronic EP  Systems

Minneapolis, MN

55432

Approval for a cable that will allow a Medtronic Radio-Frequency ablation catheter to function as a diagnostic catheter by providing connectivity to an EP recording system.  The device, as modified, will be marketed under the trade name Medtronic Model 4819 Ablation Catheter to EP Recording System cable and is indicated for use during diagnostic electrophysiologic studies in conjunction with Medtronic electrode catheters.  The cable is used during electrophysiology studies to connect the electrode catheter to the ECG recording/ stimulation equipment.

P930038/S034

12/20/02

Real-Time

Angio-Seal™ Vascular Closure Device STS PLUS Platform

St. Jude Medical, Inc.

Minnetonka, MN

55345

Approval for the addition of clinical data related to use of the Angio-Seal STS 6Fr device in diagnostic patients.

P930038/S035

12/20/02

Real-Time

Angio-Seal™ Vascular Closure Device STS PLUS Platform

St. Jude Medical, Inc.

Minnetonka, MN

55345

Approval for modifications to the insertion Sheath (addition of puncture holes), guidewire (increase guidewire size for the 6Fr. Device), puncture locator (move locator holes, label location (move to outside of package) and the Instructions for Use (revise labeling to include new instructions related to these design changes).

P950029/S016

12/18/02

180-Day

Talent II dual-sensor implantable cardiac pacemakers, Models DR233 and SR133

ELA Medical LLC

Plymouth, MN

55441

Approval for the addition of the Autosensing feature.  The device, as modified, will be marketed under the trade name Talent II, Models DR233 and SR133, and is indicated for rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or activity.  The accepted patient conditions warranting chronic cardiac pacing include: 

1) Symptomatic paroxysmal or permanent second or third degree AV block; 

2) Symptomatic bilateral bundle branch block; 

3) Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders; 

4) Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias;  5) Vasovagal syndromes or hypersensitive carotid sinus syndromes.

The Model DR233 is also indicated for dual-chamber and atrial tracking modes in patients whom may benefit from maintenance of AV synchrony.  Dual-chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include:  1) Various degrees of AV block to maintain the atrial contribution to cardiac output;  2) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.

P950037/S028

12/6/02

Real-Time

Protos Pulse Generator (Protos VR and Protos DR) and B-K00.P.U and A-K00.0.U Programmer Software

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Approval for  1) the combination of all the features of the Philos family with the Closed Loop Stimulation (CLS method of rate adaptive pacing; and  2) the addition of the Protos application to the SWM and ATA programmer software cartridges,   The device, as modified, will be marketed under the trade name Protos VR and Protos DR; and Software cartridges              B-K00.P.U and     A-K00.0.U, and is indicated for:  a) Rate adaptive pacing with the Protos Pacing System is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity.  b)  Generally accepted indications for long-term cardiac pacing include, but are not limited to: sick sinus syndrome (i.e. bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third-degree AV block, and carotid sinus syndrome.  c) Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual chamber or atrial pacing modes.  Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.

P960043/S043

12/20/02

Real-Time

Suture Trimmer for the Closer™ II 6FR. Suture-Mediated Closure (SMC) System

Perclose, Inc.

Redwood City, CA

94063

Approval for design changes to the Suture Trimmer (ST).  Specifically the ST was modified to operate by sliding rather than by cleaving the suture by cutting surface rotation.

P960052/S004

12/31/02

180-Day

Dermabond Topical Skin Adhesive, High Viscosity Product

Closure Medical Corporation

Raleigh, NC

27616

Approval for the addition of a higher viscosity product.  The device, as modified, will be marketed under the trade name High Viscosity Dermabond Topical Skin Adhesive and is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.  High Viscosity DERMABOND adhesive may be used in conjunction with, but not in place of, deep dermal stitches. 

P960053/S003

12/31/02

180-Day

Braun-Cutter Trapezo-Metacarpal Prosthesis

Avanta Orthopaedics, Inc.

Minneapolis, MN

55433

Approval for a new manufacturing facility located at RMS Co., Minneapolis, Minnesota and a new sterilization facility located at Micronet Medical, Inc., St. Paul, Minnesota.

P970029/S006

12/3/02

180-Day

CardioGenesis TMR2000 Holmium Laser System

CardioGenesis Corporation

Foothill Ranch, CA

92610

Approval for modification to the post-approval study.

P970035/S041

12/6/02

180-Day

Medtronic AVE S660, S670 & S7 with Discrete Technology™ Over-the-Wire Coronary Stent Systems

Medtronic AVE

Santa Rosa, CA

95403

Approval to modify the labeling for the Medtronic AVE S660, S670 & S7 with Discrete Technology™ Over-the-Wire Coronary Stent Systems to reflect a Minimum Guide Catheter Inner Diameter of 0.056”.

P970051/S023

12/9/02

180-Day

Nucleus 24 Cochlear Implant System

Cochlear America

Englewood, CO

80112

Approval for expansion of the manufacturing facility located at Cochlear Limited, Lane Cove, Australia.

P980008/S012

12/16/02

Real-Time

LSX Excimer Laser

Lasersight Technologies, Inc.

Winter Park, FL

32792

Approval for an increase of the pulse repetition frequency from the present value (200 Hz.) to 300 Hz.

P980016/S029

12/17/02

180-Day

Medtronic Models 7230Cx, 7230B, and 7230E Marquis® VR Single Chamber Implantable Cardioverter Defibrillator Systems with Model 9967 (Marquis® VR) Application Software, Model 9790C Programming System, and Model 2090 Programming System

Medtronic, Inc.

Minneapolis, MN

55432

Approval for Medtronic Models 7230Cx, 7230B, and 7230E Marquis® VR Single Chamber Implantable Cardioverter Defibrillator (ICD) Systems with Model 9967 (Marquis® VR) Application Software for use with the commercially available Model 9322 Patient Magnet, the Model 9790C Programming System [9790C programmer, Model 9990 Desktop Software and Model 9767/9767L Telemetry Programming Head (Telemetry B)] and with the Model 2090 Programming System [2090 programmer, Model 9986 Desktop Software and Model 2067/2067L Telemetry Programming Head (Telemetry Programming Head (Telemetry B)].  The device, as modified, will be marketed under the trade name Medtronic Marquis® VR Single Chamber Implantable Cardioverter Defibrillator System and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

P980018/S001

12/12/02

Real-Time

DAKO HercepTest®

DakoCytomation California, Inc.

Carpinteria, CA

93013

Approval for minor labeling changes.

P980041/S002

12/6/02

180-Day

ACCESS AFP Assay on the SYNCHRON LXi 725 System

Beckman Coulter, Inc.

Brea, CA

92821

Approval for expanding the use of the AFP Immunoassay on the SYNCHRON LXi 725 System.  The device, as modified, will be marketed under the tradename ACCESS AFP Immunoassay System and is indicated for the quantitative determination of alpha-fetoprotein (AFP) in:  1) Human serum, as an aid in the management of patients with non-seminomatous testicular cancer.  2) Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD).  Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD.  The assay is intended for use in conjunction  with other diagnostic tools such as ultrasound and amniography.

P980046/S005

12/6/02

180-Day

Home Access Hepatitis C Test

Home Access Health Corporation

Hoffman Estates, IL

60195

Approval for a reduction of a supplement testing range (STR) from specimens with a signal-to-cutoff value from 5.0 to 4.2.

P990020/S010

12/23/02

180-Day

The AneuRx™ Stent Graft with Xpedient Delivery System

Medtronic AVE

Santa Rosa, CA

95403

Approval for the format to be used for a clinical update that will be provided to physician users at least annually.  The information contained in this update will be provided to the FDA via the PMA Annual Report.

P990025/S004

12/18/02

180-Day

QwikStar™ Diagnostic/Ablation Catheters (Models D-1229 and D-1230) and QwikStar™ Interface Cable (Model D-1195-12)

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for a new interface cable and design changes (e.g., additional location sensor) to the catheter previously approved under P990025 and it’s supplements, in order to enable additional mapping capabilities.

P000009/S005

12/20/02

Real-Time

Belos DR and

Belos DR-T Dual-Chamber Implantable Cardioverter Defibrillator (ICD) Systems

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Approval for  1) new additional pulse generators to the Belos family of implantable cardioverter defibrillators, and  2) modifications to the legally marketed Belos VR/VR-T ICD Systems.  The device, as modified, will be marketed under the trade name Belos DR, DR-T, VR, VR-T ICD Systems and is indicated for ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life threatening ventricular arrhymias.

P000015/S003

12/9/02

180-Day

Nucleus 24 Auditory Brainstem Implant

Cochlear America

Englewood, CO

80112

Approval for expansion of the manufacturing facility located at Cochlear Limited, Lane Cove, Australia.

P000028/S002

12/3/02

180-Day

AFFINITY™ Anterior Cervical Cage System

Medtronic Sofamor Danek

Memphis, TN

38132

Approval for the post-approval study protocol for the AFFINITY™ Anterior Cervical Cage System.

P000029/S003

12/13/02

Real-Time

Deflux® Injectable Gel

Q-Med Scandinavia, Inc.

Herndon, VA

20171

Approval for an increase in the labeled storage temperature to 25 º C and an expiration date of 18 months after manufacture.

P000046/S004

12/3/02

180-Day

STAARVISC™ II, SHELLGEL™, and Coease™ Viscoelastics

Anika Therapeutics

Woburn, MA

01801

Approval for a buffered formulation (pH 6.8 – 7.6) for STAARVISC™ II, SHELLGEL™, and Coease Viscoelastics.

P000052/S009

12/10/02

180-Day

GALILEO™ and GALILEO III™ Intravascular Radiotherapy Systems

Guidant Corporation

Houston, TX

77054

Approval for modifications to the cartridge shipping container and the addition of an electrostatic discharge warning label on the cartridge.

P000052/S014

12/17/02

Special

GALILEO III™ Intravascular Radiotherapy Systems

Guidant Corporation

Houston, TX

77054

Approval to include a warning statement in the Instructions for Use for the GALILEO® III Centering Catheter advising the user not to exceed a pressure of 4 atm, as possible overexpansion of the inflation lumen could result.

P010012/S002

12/20/02

180-Day

Contak Renewal Cardiac Resynchronization System

Guidant Corporation

St. Paul, MN

55112

Approval for the commercial introduction of the Contak Renewal Model H135 Cardiac Resynchronization Therapy Defibrillator (CRT-D) and the Model 2845 Version 1.7 Software.  The device, as modified, will be marketed under the trade name Contak Renewal and is indicated as follows:  The CONTAK RENEWAL heart failure device system is indicated for use in the following:  Patients who are at high risk of sudden cardiac death due to ventricular arrhythmias and who have moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF <35%) and QRS during >120 ms and remain symptomatic despite stable, optimal heart failure drug therapy.  Patient populations at high risk of sudden cardiac death due to ventricular arrhythmias include, but are not limited to, those with: 

1) Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to a ventricular tachyarrhythmia. 

2) Recurrent, poorly tolerated sustained ventricular tachycardia (VT).  NOTE: The clinical outcome of hemodynamically stable, sustained-VT patients is not fully known.  Safety and effectiveness studies have not been conducted.  3) Prior myocardial infarction, left ventricular ejection fraction of <35%, and a documented episode of nonsustained VT, with an inducible ventricular tachyarrhythmia.  4) Patients suppressible with IV procainamide or an equivalent antiarrhythmic (drug) have not been studied.

P010012/S005

12/30/02

Real-Time

FINISHING WIRE® Universal, Models 6001-6007

Guidant Corporation

St. Paul, MN

55112

Approval for a modification to the EasyTrak Finishing Wire.  The device, as modified, will be marketed under the trade name FINISHING WIRE Universal®, Models 6001 – 6007 and is indicated for use with Guidant Coronary Venous Leads.

P010015/S007

12/23/02

180-Day

Attain™ OTW 4193 Left Ventricular Pacing Lead

Medtronic, Inc.

Minneapolis, MN

55432

Approval of the post-approval study for the device.

P010032/S005

12/23/02

Real-Time

Genesis Neurostimulation (IPG) System

Advanced Neuromodulation

systems, Inc.

Plano, TX

75024

Approval for the Quick Link Controller Model 3860 for use with the Genesis Model 3608, 3609, 3644 and 3604 Implanted Pulse Generators 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.

P010032/S006

12/23/02

Real-Time

Genesis G4 Neurostimulation (IPG) System (Model 3604)

Advanced Neuromodulation Systems, Inc.

Plano, TX

75024

Approval for the Genesis G4 Neurostimulation (IPG) System (Model 3604) which is 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.

P820076/S023

12/20/02

Permanent Pacemaker Electrode

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Reduction in the incubation time of the biological indicators utilized during the standard sterilization process, from 7 days to 3 days.

P830060/S051

12/13/02

VENTAK leads and accessories

Guidant Corporation

St. Paul, MN

55112

Change in the manufacturing process to the parametric release method, which involves sterile product release based on conformance to pre-defined sterilization parameters rather than a release based on demonstrating no growth in biological indicator.

P860003/S042

12/20/02

UVAR® XTS™ Photopheresis System

Therakos, Inc.

Exton, PA

19341

Change in the sterilization process for the UVAR® XTS™ Photopheresis System.

P860057/S020

12/31/02

Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis

Edwards Lifesciences LLC

Irvine, CA

92614

Change in the method to reduce bioburden.

P870056/S016

12/31/02

Carpentier-Edwards® Bioprosthesis

Edwards Lifesciences LLC

Irvine, CA

92614

Change in the method to reduce bioburden.

P870077/S014

12/31/02

Carpentier-Edwards® Duraflex® Low Pressure Bioprosthesis

Edwards Lifesciences LLC

Irvine, CA

92614

Change in the method to reduce bioburden.

P910073/S040

12/13/02

ENDOTAK/ ENDURANCE/ RELIANCE leads and accessories

Guidant Corporation

St. Paul, MN

55112

Change in the manufacturing process to the parametric release method, which involves sterile product release based on conformance to pre-defined sterilization parameters rather than a release based on demonstrating no growth in biological indicator.

P910077/S038

12/13/02

VENTAK PRx leads and accessories

Guidant Corporation

St. Paul, MN

55112

Change in the manufacturing process to the parametric release method, which involves sterile product release based on conformance to pre-defined sterilization parameters rather than a release based on demonstrating no growth in biological indicator.

P930035/S010

12/13/02

VENTAK P2 leads and accessories

Guidant Corporation

St. Paul, MN

55112

Change in the manufacturing process to the parametric release method, which involves sterile product release based on conformance to pre-defined sterilization parameters rather than a release based on demonstrating no growth in biological indicator.

P940008/S017

12/13/02

RES-Q accessories

Guidant Corporation

St. Paul, MN

55112

Change in the manufacturing process to the parametric release method, which involves sterile product release based on conformance to pre-defined sterilization parameters rather than a release based on demonstrating no growth in biological indicator.

P950001/S009

12/13/02

SELUTE leads and accessories

Guidant Corporation

St. Paul, MN

55112

Change in the manufacturing process to the parametric release method, which involves sterile product release based on conformance to pre-defined sterilization parameters rather than a release based on demonstrating no growth in biological indicator.

P950037/S029

12/20/02

Protos Family of Pulse Generators

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Reduction in the incubation time of the biological indicators utilized during the standard sterilization process, from 7 days to 3 days.

P960004/S021

12/13/02

THINLINE/ FINELINE leads and accessories

Guidant Corporation

St. Paul, MN

55112

Change in the manufacturing process to the parametric release method, which involves sterile product release based on conformance to pre-defined sterilization parameters rather than a release based on demonstrating no growth in biological indicator.

P960006/S007

12/13/02

SWEETTIP Rx/ SWEET PICOTIP Rx/FLEXTEND

Guidant Corporation

St. Paul, MN

55112

Change in the manufacturing process to the parametric release method, which involves sterile product release based on conformance to pre-defined sterilization parameters rather than a release based on demonstrating no growth in biological indicator.

P980023/S011

12/20/02

Implantable Cardioverter Defibrillator

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Reduction in the incubation time of the biological indicators utilized during the standard sterilization process, from 7 days to 3 days.

P990026/S016

12/31/02

GlucoWatch® G2™ Biographer

Cygnus, Inc.

Redwood City, CA

94063

Change in the PCBA wash process in the PCBA assembly sequence to increase the efficiency of the process and to reduce cost.

P000009/S006

12/20/02

Implantable Cardioverter Defibrillator

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Reduction in the incubation time of the biological indicators utilized during the standard sterilization process, from 7 days to 3 days.

P000029/S002

12/18/02

Deflux® Injectable Gel

Q-Med Scandinavia, Inc.

Herndon, VA

20171

Change in site for bacterial endotoxin testing for the Deflux Needle, a component of the Deflux device.  The testing is currently conducted at a contract facility, NAMSA, and will be moved to Q-Med’s Microbiology QC laboratory in Uppsala, Sweden.  There will also be a change of test method from Kinetic-Chromogenic LAL procedure to the gel clot LAL test.

P000049/S007

12/23/02

CardioSeal Septal Occlusion System with QwikLoad

NMT Medical, Inc.

Boston, MA

02210

Change in the manufacturing process to add an alternate vendor for the delivery system y-body assembly.

P010012/S006

12/13/02

CONTAK CD/ EASYTRAK leads and accessories

Guidant Corporation

St. Paul, MN

55112

Change in the manufacturing process to the parametric release method, which involves sterile product release based on conformance to pre-defined sterilization parameters rather than a release based on demonstrating no growth in biological indicator.

P010033/S002

12/17/02

QuantiFERON-TB

Cellestis, Inc.

Valencia, CA

91355

Change in the substrate reagent used in the kit from a two-solution substrate system to a one-solution substrate system.

P010041/S003

12/31/02

Carpentier-Edwards® Supraannular (S.A.V.®) Bioprosthesis

Edwards Lifesciences LLC

Irvine, CA

92614

Change in the method to reduce bioburden.