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PMA Final Decisions Rendered for October 2003

P010059

10/23/03

Morcher Capsular Tension Ring, Types 14, 14A and 14C

Morcher GmbH

Wurttemberg-Baden, Germany

D-70374

Approval for the Morcher Capsular Tension Ring, Types 14, 14A and 14C.  The device is indicated for the stabilization of the crystalline lens capsule in the presence of weak or partially absent zonules in adult patients undergoing cataract extraction with intraocular lens implantation.  Conditions associated with weak or partially absent zonules may include primary zonular weakness (e.g., Marfan’s Syndrome), secondary zonular weakness (e.g., trauma or vitrectomy) cases of zonulysis, cases of pseudoexfoliation and cases of Marchesani’s Syndrome.

P020040

10/24/03

NIRflex™ Pre-mounted Coronary Stent System

Medinol Ltd.

Tel-Aviv, Israel

68581

Approval for the NIRflex™ Pre-mounted Coronary Stent System.  The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo and restenotic lesions in native coronary arteries (length ≤ 25 mm) with a reference vessel diameter from 2.5 mm to 4.0 mm.

P020050

10/7/03

WaveLight ALLEGRETTO WAVE™ Excimer Laser System

Wavelight Laser Technologies

Erlangen, Germany

91058

Approval for the WaveLight ALLEGRETTO WAVE™ Excimer Laser System.  The device used optical zones of 6.0 and 6.5 mm with an ablation/treatment zone up to 9.0 mm, and is indicated for laser assisted in situ keratomileusis (LASIK):  1) for the reduction or elimination of myopia of up to -12.0 diopters (D) of sphere and up to -6.0 D of astigmatism at the spectacle plane;  2) in patients who are 18 years of age or older; and  3) in patients with documentation of a stable manifest refraction defined as ≤0.50D of preoperative spherical equivalent shift over one year prior to surgery.

P030008

10/10/03

WaveLight ALLEGRETTO WAVE™ Excimer Laser System

Wavelight Laser Technologies

Erlangen, Germany

91058

Approval for the WaveLight ALLEGRETTO WAVE™ Excimer Laser System.  The devices uses optical zones of 6.0 and 6.5 mm with an ablation/treatment zone up to 9.0 mm, and is indicated for laser assisted in situ keratomileusis (LASIK):  1) for the reduction or elimination of hyperopic refractive errors up to +6.0 diopters (D) of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D;  2) in patients who are 18 years of age or older; and  3) in patients with documentation of a stable manifest refraction defined as <=0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia.

P030009

10/1/03

Driver™ Over-The-Wire, Rapid Exchange, and Multi-Exchange Coronary Stent Systems.

Medtronic Vascular

Santa Rosa, CA

95403

Approval for the Driver Over-The-Wire, Rapid Exchange, and Multi-Exchange Coronary Stent Systems.  These devices are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions with reference vessel diameters of 3.0 – 4.0 mm and ≤ 30 mm in length using direct stenting or pre-dilatation.  Outcome beyond 270 days for this permanent implant is unknown at present.

P820088/S016

10/8/03

180-Day

BSD-500 Hyperthermia System

BSD Medical Corporation

Salt Lake City, UT

84119

Approval to replace the computer and monitor and for the minor upgrade for thermometry calibration method.

P830045/S088

10/17/03

Real-Time

Atlas™+ DR/VR Implantable Cardioverter Defibrillators, Models V-242,

V-243, V-193 and V-193C, Epic+ Models V-233,

V-239 and V196, and Model 3307 v.4.5a Software

St. Jude Medical

Sunnyvale, CA

94086

Approval for modifications to the Epic+ ICDs to include higher energy output, software modifications, and a different header type.  The device, as modified, will be marketed under the trade name Atlas™+ DR/VR Implantable Cardioverter Defibrillators, Models V-242,

V-243, V-193 and V-193C, Epic+ Models V-233,

V-239 and V196, and Model 3307 v.4.5a Software, and is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.  AF suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indications.

P830045/S089

10/31/03

Real-Time

Model 3510 Programmer and Model 3134 External Video Cable

St. Jude Medical

Sylmar, CA

91342

Approval for modification to the Model 3510 programmer platform by adding a video display out port and the addition of a new video cable, Model 3134.

P860019/S195

10/17/03

135-Day

Quantum™, Maverick™, and Monorail™ Over-The-Wire PTCA Catheters

Boston Scientific Corporation

Maple Grove, MN

55311

Approval for an alternate process to form and fold the balloon wings.

P880047/S008

10/21/03

180-Day

INTERCEED (TC7) Absorbable Adhesion Barrier

Gynecare, a division of Ethicon, Inc.

Somerville, NJ

08876

Approval for a sterilization facility located at Steris-Isomedix Services, Vega Alta, Puerto Rico.

P880086/S096

10/17/03

Real-Time

Atlas™+ DR/VR Implantable Cardioverter Defibrillators, Models V-242,

V-243, V-193 and V-193C, Epic+ Models V-233,

V-239 and V196, and Model 3307 v.4.5a Software

St. Jude Medical

Sunnyvale, CA

94086

Approval for modifications to the Epic+ ICDs to include higher energy output, software modifications, and a different header type.  The device, as modified, will be marketed under the trade name Atlas™+ DR/VR Implantable Cardioverter Defibrillators, Models V-242,

V-243, V-193 and V-193C, Epic+ Models V-233,

V-239 and V196, and Model 3307 v.4.5a Software, and is intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.  AF suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indications.

P880086/S097

10/31/03

Real-Time

Model 3510 Programmer and Model 3134 External Video Cable

St. Jude Medical

Sylmar, CA

91342

Approval for modification to the Model 3510 programmer platform by adding a video display out port and the addition of a new video cable, Model 3134.

P900056/S078

10/22/03

Special

RotaWire™ Floppy Gold Guide Wire

Boston Scientific Corporation

Maple Grove, MN

55311

Approval for changes to the RotaWire gold plating manufacturing equipment and monitoring.

P910023/S069

10/17/03

Real-Time

Atlas™+ DR/VR Implantable Cardioverter Defibrillators, Models V-242,

V-243, V-193 and V-193C, Epic+ Models V-233,

V-239 and V196, and Model 3307 v.4.5a Software

St. Jude Medical

Sunnyvale, CA

94086

Approval for modifications to the Epic+ ICDs to include higher energy output, software modifications, and a different header type.  The device, as modified, will be marketed under the trade name Atlas™+ DR/VR Implantable Cardioverter Defibrillators, Models V-242,

V-243, V-193 and V-193C, Epic+ Models V-233,

V-239 and V196, and Model 3307 v.4.5a Software, and is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.  AF suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indications.

P920014/S021

10/31/03

180-Day

Thoratec® HeartMate® XVE Left Ventricular Assist System (LVAS)

Thoratec Corporation

Pleasanton, CA

95488

Approval for the use of a new inflow valve assembly design for the Thoratec HeartMate XVE LVAS.

P940031/S028

10/31/03

Real-Time

Software Application Model 2890 version 4.10

Guidant Corporation

St. Paul, MN

55112

Approval for modifications to the software applications for the PULSAR, PULSAR MAX, DISCOVERY, MERIDIAN, CONTAK TR, PULSAR MAX II, and DISCOVERY II pacemaker systems.

P950002/S012

10/31/03

Real-Time

BAK™ VISTA™ Interbody Fusion Cage

Centerpulse Spine-Tech, Inc.

Minneapolis, MN

55439

Approval to add the 9mm x 20mm BAK™ VISTA™ Interbody Fusion Device, which is manufactured from 65% PEEK Optima® and 35% TOHO BESFIGHT® C6-UH carbon fiber, to the approved product line for the BAK Interbody Fusion System.  The device will be marketed under the trade name BAK™ VISTA™ Interbody Fusion Device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at the L2-S1 levels.  These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).  BAK devices are to be implanted via an open anterior or posterior approach.  DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.  These patients would be skeletally mature and have had six months of non-operative treatment.

P950019/S016

10/10/03

Special

Ray TFC UNITE™

Stryker Howmedica Osteonics

Allendale, NJ

07401

Approval for labeling changes (change of address, change in CE mark, additional patent statement) and changes in part numbers.

P950029/S017

10/24/03

180-Day

Symphony/ELA Rhapsody Pacemaker System

ELA Medical, Inc.

Plymouth, MN

55441

Approval for new pacemaker models, Symphony Models 2550, and 2250 and ELA Rhapsody Models 2530, 2510 and 2210.  The Symphony and ELA Rhapsody pacemaker systems are indicated for:  1) Rate Adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or activity.  2) The accepted patient conditions warranting chronic cardiac pacing which include, but are not restricted to: a) symptomatic paroxysmal or permanent second- or third-degree AV block; b) symptomatic bilateral bundle branch block; c) symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders: d) Bradycardia-tachycardia syndrome to prevent symptomatic Bradycardia or some forms of symptomatic tachyarrhythmias; e) vasovagal syndromes or hypersensitive carotid sinus syndromes.  In addition, the dual-chamber and atrial tracking modes (Sympohony DR Model 2550 and ELA Rhapsody DR Models 2530 and 2510) are indicated for patitnes who 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; and 2) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.

P960016/S013

10/3/03

Special

Livewire TC™ Steerable Electrophysiology Catheter

St. Jude Medical, Daig Division, Inc.

Minnetonka, MN

55345

Approval for changes to the instructions for use to include warnings regarding proper movement of the catheter.

P960040/S032

10/22/03

180-Day

VITALITY™ Automatic Implantable Cardioverter Defibrillator (AICD) Systems and Model 2857 Software, version 1.6

Guidant Corporation

St. Paul, MN

55112

Approval to enable the Automatic Intrinsic RHYTHM ID™ algorithm update feature.  The device, as modified, will be marketed under the trade name VITALITY™ VR/DR/

VITALITY™+ DR AICD Systems and the Programmer Software Application Model 2857 Version 1.6 and is indicated for use as follows:  The VITALITY™ VR/DR/

VITALITY™+ DR AICE system is indicated for use in patients who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias.  In addition, this device is indicated for prophylactic treatment of patients with a prior myocardial infarction and EF <30%.

P960040/S035

10/6/03

Real-Time

VENTAK® VITALITY™ AVT™ AICD™, Models A135 and A155, Model 2920 Programmer with Model 2812 Application Software Version 1.2

Guidant Corporation

St. Paul, MN

55112

Approval for a fast-charge version of the device (Model A155) and to correct software anomalies (Models A155 and A135).  The device, as modified, will be marketed under the trade name VENTAK® VITALITY™ AVT™ AICD™ system and is indicated as follows:  The VITALITY AVT AICD System is indicated for use in patients who are ICD indicated and who have atrial tachyarrhythmias or who are at risk of developing atrial tachyarrhythmias.  Patient populations who are indicated for a Guidant ICD include those who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias; or, patients who may benefit from prophylactic treatment due to a prior myocardial infarction and an ejection fraction <=30%.

D970003/S023

10/9/03

Real-Time

INSIGNIA® I Entra/Plus Implantable Pacemaker System

Guidant Corporation

St. Paul, MN

55112

Approval to modify the labeling to include the Clinical Study Summary from the approved PULSAR MAX pacemaker.

D970003/S025

10/31/03

Real-Time

Software Application Model 2891 version 2.11

Guidant Corporation

St. Paul, MN

55112

Approval for modifications to the software applications for the PULSAR, PULSAR MAX, DISCOVERY, MERIDIAN, CONTAK TR, PULSAR MAX II, and DISCOVERY II pacemaker systems.

P970003/S048

10/22/03

Special

NeuroCybernetic Prosthesis (NCP®) System

Cyberonics, Inc.

Houston, TX

77058

Approval for a change to the precaution regarding bradycardia and/or asystole.

D970012/S018

10/7/03

Real-Time

AMS 700™ Series Inflatable Penile Prosthesis Product Line

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for the addition of the Proximal Tool to the accessory kit for the AMS 700™ Series Inflatable Penile Prosthesis Product Line.

P970018/S005

10/27/03

180-Day

PrepStain System

TriPath Imaging, Inc.

Redmond, WA

98052

Approval for a manufacturing site located in Burlington, North Carolina.

P980016/S037

10/6/03

Real-Time

Medtronic Model 7278 Maximo™ DR ICD and Model 7232 Maximo™ VR ICD Systems, with Model 9978 version 1.0 application software (Maximo™ DR) and Model 9979 version 1.0 application software (Maximo™ VR)

Medtronic, Inc.

Minneapolis, MN

55432

Approval to modify the Marquis VR and DR systems to provide increased energy output.  The devices will be used with the following application software versions: Model 9978 version 1.0 application software for use with the Maximo™ DR, and Model 9979 version 1.0 application software for use with Maximo™ VR.  The application software may be installed on either 9790C or 2090 programmers.  The devices, as modified, will be marketed under the trade name Maximo™ DR/VR ICD System and are indicated as follows:  The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

P980016/S038

10/23/03

Real-Time

Medtronic Marquis DR Model 7274, Marquis VR Model 7230, Maximo™ DR Model 7278 and Maximo™ VR Model 7232

Medtronic, Inc.

Minneapolis, MN

55432

Approval for battery changes to the Chi 4420L Battery in the Medtronic Marquis DR Model 7274, Marquis VR Model 7230, Maximo™ DR Model 7278, Maximo™ VR Model 7232, InSync Marquis Model 7277 and the InSync II Marquis Model 7289.     

P980023/S015

10/31/03

180-Day

Cardiac Airbag Implantable Cardioverter Defibrillators

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Approval of the post-approval study for the device.

P980035/S028

10/3/03

180-Day

Medtronic AT500 DDDRP Pacing System (Model AT501) and Model 9968 Software

Medtronic, Inc.

Minneapolis, MN

55432

Approval of the post-approval study.

P980049/S010

10/14/03

Real-Time

CPR3 Programming head for the Orchestra Programmer

ELA Medical, LLC

Plymouth, MN

55441

Approval for modifications to the programming head of the Orchestra Programmer, including the addition of high-speed telemetry and other changes.  The device, as modified, will be marketed under the trade name CPR3 Programming Head and is indicated for use with the Orchestra dedicated programmer to interrogate and program ELA Medical Pulse generators via bi-directional telemetry.

P980049/S011

10/21/03

Real-Time

Orchestra Application Software (Elaview 1.20 UG1)

ELA Medical, LLC

Plymouth, MN

55441

Approval for the Orchestra Application Software (Elaview 1.20 UG1) which allows high-speed telemetry and correct minor anomalies.

P990027/S006

10/10/03

Panel

Bausch & Lomb TECHNOLAS® 217z Zyoptix System for Personalized Vision Correction

Bausch & Lomb, Inc.

Irvine, CA

91773

Approval for the Bausch & Lomb TECHNOLAS 217z Zyoptix System for Personalized Vision Correction.  The device uses an optical zone size between 6.0 mm and 7.0 mm with a constant blend zone of 0.875 mm, and is indicated for wavefront-guided laser assisted in-situ keratomileusis (LASIK):  1) for the reduction or elimination of myopia with sphere up to -7.00 D and cylinder up to -3.00 D and MRSE ≤7.50 D at the spectacle plane;  2) in patients with documented evidence of a change in manifest refraction of less than or equal to ±0.50 diopters (in both cylinder and sphere components) for at least one year prior to the date of the pre-operative examination;  and 3) in patients 21 years of age or older.

P000009/S010

10/14/03

Real-Time

Belos DR, Belos DR-T, Belos VR, Belos VR-T, Cardiac Airbag and Cardiac Airbag-T Implantable Cardioverter Defibrillators and Programmer Software (A-K00.1.U/2)

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for programmer software changes to correct anomalous behavior for the Belos and Cardiac Airbag Families of implantable cardioverter defibrillator (ICD) Systems.

P000016/S002

10/15/03

Special

Corometrics Model 120F-Series Maternal/Fetal Monitor w/Integrated Fetal Oxygen Saturation Monitoring

GE Medical Systems Information Technologies

Tampa, FL

33614

Approval for modifications to the labeling.

P000018/S027

10/23/03

135-Day

Novoste™

Beta-Cath™ System

Novoste

Norcross, GA

30093

Approval to change an electronic data management system, referred to as the BetaCal System.

P000023/S004

10/14/03

180-Day

TMJ Fossa-Eminence/Condylar Prosthesis System and TMJ Fossa-

Eminence Prosthesis

TMJ Implants, Inc.

Golden, CO

80401

Approval for the packaging/shelf life testing protocol to extend the shelf life beyond 6 months.

P000035/S004

10/14/03

180-Day

TMJ Fossa-Eminence/Condylar Prosthesis System and TMJ Fossa-

Eminence Prosthesis

TMJ Implants, Inc.

Golden, CO

80401

Approval for the packaging/shelf life testing protocol to extend the shelf life beyond 6 months.

P010012/S014

10/21/03

180-Day

CONTAK CD (Model 1823), CONTAK CD2 (Model H115, H119), RENEWAL (Models H135) and RENEWAL 3 (Models H170, H175, H177, H179)

Guidant Corporation

St. Paul, MN

55112

P010012/S016

10/24/03

Real-Time

Contak Renewal, Contak Renewal 3

Guidant Corporation

St. Paul, MN

55112

Approval for labeling changes to the system guide and technical manuals for the Contak Renewal and Contak Renewal 3 systems.

P010025/S003

10/10/03

180-Day

Selenia Full Field Digital Mammography (FFDM) System

LORAD, A Hologic Company

Danbury, CT

06810

Approval for the following user enhancements and components; an additional Peripheral Contrast Enhancement (PCE) based image processing mechanism;  the addition of a high resolution Fuji FM-DP L image printer; and updated labeling changes for the Selenia™ Full Field Digital Mammography System (FFDM).

P010031/S010

10/23/03

Real-Time

InSync Marquis Model 7277 and the InSync II Marquis Model 7289

Medtronic, Inc.

Minneapolis, MN

55432

Approval for battery changes to the Chi 4420L Battery in the Medtronic Marquis DR Model 7274, Marquis VR Model 7230, Maximo™ DR Model 7278, Maximo™ VR Model 7232, InSync Marquis Model 7277 and the InSync II Marquis Model 7289.     

P010034/S004

10/31/03

180-Day

Second Look Analog 6.0 Computer-Aided Detection (CAD) System for Mammography

CADx Systems, Inc.

Beavercreek, OH

45431

Approval for three user preferred threshold settings for the performance of Second Look Analog 6.0 CAD System, updated CAD algorighms to increase sensitivity, and new updated commercial database driver for improved speed and reliability for the system.

P010034/S005

10/8/03

Real-Time

Second Look® Digital CAD System for Mammography

CADx Systems, Inc.

Beavercreek, OH

45431

Approval for the use of the Second Look® Digital CAD System for Mammography with the Fisher Imaging’s SenoScan® Full Field Digital Mammography System.

P010038/S004

10/10/03

180-Day

iCAD System

iCAD, Inc.

Tampa, FL

33634

Approval for a change in the mammography film digitizer from the formerly approved MultiRad 860 to the Fulcrum.

P010038/S005

10/31/03

180-Day

iCAD System

iCAD, Inc.

Tampa, FL

33634

Approval for  1) an upgraded algorithm for the iCAD System,  2) use of the iCAD System directly with images obtained on the Fischer SenoScan FFDM System, and  3) the new inclusion of women with breast implants in the target population in the indications for use (IFU).  The device, as modified, will be marketed under the trade name iCAD System with the following indications for use:  The iCAD is a computer system intended to identify and mark regions of interest on standard mammographic views, including views from cases for patients with breast implants and images from qualified Full Field Digital Mammography systems, to bring them to the attention of the radiologist after the initial reading has been completed.  Thus the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.

P020004/S004

10/15/03

180-Day

Gore EXCLUDER™ Bifurcated Endoprosthesis

W.L. Gore & Associated, Inc.

Flagstaff, AZ

86001

Approval for the addition of larger size contralateral leg components for the EXCLUDER Bifurcated Endoprosthesis (EBE) and for the addition of the W.L. Gore & Associates Woody

Springs Facility located in Flagstaff, Arizona, which will be used to manufacture the larger sized contralateral leg components.

P020009/S012

10/24/03

Special

Express™ and Express2™ Monorail and Over-the-Wire Coronary Stent Systems

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval to add a quality control test to evaluate the elongation property of the extruded distal outer shaft component for the Express2™ stent delivery catheter.

P020026/S001

10/21/03

180-Day

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

Cordis Corporation

Miami Lakes, FL

33014

Approval for an additional test lab for post-sterile analytical testing.  The facility is located at Cardinal Health Pharmaceutical Technologies and Services

Center, Somerset, New Jersey.

P020026/S003

10/10/03

Real-Time

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

Cordis Corporation

Miami Lakes, FL

33014

Approval for the addition of a second identity method for rapamycin in CYPHER™ Sirolimus-eluting coronary stents.  This method will be performed in conjunction with the currently approved identity method.  The addition of the second identity method is in accordance with one of the conditions of approval commitments made for this PMA.

P020027/S001

10/10/03

Real-Time

Dimension® FPSA Flex® Reagent Cartridge

Dade Behring, Inc.

Newark DE

19714

Approval of the following modifications to the Dimension® FPSA Flex® Reagent Cartridge:  1) Addition of lithium heparin plasma as a sample type in the intended use and the package labeling.  2) Addition of the disclaimer “results of this test should always be interpreted in conjunction with the patient’s medical history, clinical presentation and other findings” to the Results section of the package labeling.  3) Correction of the units for IgG in the package labeling from 6 g/mL to 6 g/dL.  The device, as modified, will be marketed under the same trade name, Dimension® FPSA Flex® Reagent Cartridge and is indicated as follows:  The FPSA method for the Dimension® clinical chemistry system with the heterogenous immunoassay module is an in vitro diagnostic test intended to quantitatively measure free prostate specific antigen (FPSA) in human serum and plasma.  Measurements of FPSA are used in conjunction with total PSA (TPSA) on the Dimension® system to calculate FPSA to TPSA ratio expressed as percent

FPSA.  The percent FPSA is used as an aid in distinguishing prostate cancer from benign prostate conditions in men 50 years or older with TPSA of 4.0 to 10/0 ng/mL (µg/L) and digital rectal examination (DRE) findings not suspicious for cancer.  Prostate biopsy is required for diagnosis of prostate cancer.

P020045/S002

10/28/03

Real-Time

7F Freezor® Cardiac CryoAblation Catheter and CCT.2 CryoConsole System

Cryocath Technologies, Inc.

Brookline, MA

02445

Approval for manufacturing and minor design changes to the CCT.2 CryoConsole.

P020047/S001

10/8/03

Special

MULTI-LINK RX and OTW Vision™ Coronary Stent Systems

Guidant Corporation

Santa Clara, CA

95054

Approval for the addition of a temporary, post-sterile sampling inspection plan for the Small (3.0 mm diameter) Multi-Link VISION Coronary Stent System.

P950032/S036

10/24/03

Apligraf™

Organogenesis, Inc.

Canton, MA

02021

Change from individual medium components to a bulk medium formulation and change in the method of delivering the keratinocytes to form a bilayered dermal-epidermal construct.

P000018/S036

10/9/03

Novoste™

Beta-Cath™ System

Novoste Corp.

Norcross, GA

30093

Change in the Beta-Cath Transfer Devices inspection process.

P000018/S037

10/9/03

Novoste™

Beta-Cath™ System

Novoste Corp.

Norcross, GA

30093

Change in the hydraulic pressure used in the functional source train transport inspection of the Delivery Catheter.

P000018/S038

10/14/03

Novoste™

Beta-Cath™ System

Novoste Corp.

Norcross, GA

30093

Change in the suppliers of two components used in the routine maintenance and serving of the Alpha Transfer Devices.

P020009/S011

10/28/03

Express/

Express2™ Coronary Stent System

Boston Scientific Corporation

Maple Grove, MN

55311

Change to partial automation of the stent finishing process.