Premarket Approval Decisions for April 2003

Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for March 2002. 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. Information about the PDF Reader is available.

APPLICATION NUMBER / DATE OF APPROVAL	DEVICE TRADE NAME	COMPANY NAME, CITY, STATE AND ZIP	DEVICE DESCRIPTION / INDICATIONS
P020006 4/22/03	Enteryx™ Procedure Kit	Enteric Medical Technologies, Inc. Foster City, CA 94404	Approval for the Enteryx™ Procedure Kit. The device is indicated for endoscopic injection into the region of the lower esophageal sphincter (LES) for the treatment of gastroesophageal reflux disease (GERD) symptoms in patients responding to and requiring daily pharmacological therapy with proton pump inhibitors.
P020026 4/24/03	CYPHER™ Sirolimus-Eluting Coronary Stent on the RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System	Cordis Corporation Miami Lakes, FL 33102	Approval for the CYPHER™ Sirolimus-Eluting Coronary Stent on the RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System. The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length ≤ 30 mm in native coronary arteries with a reference vessel diameter of ≥ 2.5 to ≤ 3.5 mm. Long-term outcome (beyond 12 months) for this permanent implant is unknown at present.
P020045 4/17/03	7F Freezor® Cardiac CryoAblation Catheter and CCT.2 CryoConsole System	CryoCath Technologies, Inc. Kirkland, Canada H9H 5H3	Approval for the 7F Freezor® Cardiac CryoAblation Catheter and CCT.2 CryoConsole System. The device is indicated for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT).

APPLICATION NUMBER / DATE OF APPROVAL

DEVICE TRADE NAME

COMPANY NAME, CITY, STATE AND ZIP

DEVICE DESCRIPTION / INDICATIONS

P020006

4/22/03

Enteryx™ Procedure Kit

Enteric Medical Technologies, Inc.

Foster City, CA

94404

Approval for the Enteryx™ Procedure Kit. The device is indicated for endoscopic injection into the region of the lower esophageal sphincter (LES) for the treatment of gastroesophageal reflux disease (GERD) symptoms in patients responding to and requiring daily pharmacological therapy with proton pump inhibitors.

P020026

4/24/03

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

Cordis Corporation

Miami Lakes, FL

33102

Approval for the CYPHER™ Sirolimus-Eluting Coronary Stent on the RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System. The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length ≤ 30 mm in native coronary arteries with a reference vessel diameter of ≥ 2.5 to ≤ 3.5 mm. Long-term outcome (beyond 12 months) for this permanent implant is unknown at present.

P020045

4/17/03

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

CryoCath Technologies, Inc.

Kirkland, Canada

H9H 5H3

Approval for the 7F Freezor® Cardiac CryoAblation Catheter and CCT.2 CryoConsole System. The device is indicated for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT).

APPLICATION NUMBER / DATE OF APPROVAL	DEVICE TRADE NAME	COMPANY NAME, CITY, STATE AND ZIP	DEVICE DESCRIPTION / INDICATIONS
N18286/S014 4/21/03 Special	Gelfoam Absorbable Gelatin Sponge	Pharmacia & Upjohn Kalamazoo, MI 49001	Approval for modified labeling discussing the use of Gelfoam with bovine thrombin.
P830045/S084 4/23/03 180-Day	Application Software Model 3307 (version 4.3a), Bradycardia family of devices: Addvent®, Affinity®, Aurora™, Dialog® II, Entity®, Identity™, Integrity®, Meta™, Microny®, Multilog™, Paragon™, Phoenix®, Quadra™, Reflex®, Regency®, Sensolog® III, Sensorithm™, Simplex™, Solus®, Synchrony®, Tempo™ and Trilogy® families	St. Jude Medical, Inc. Sunnyvale, Ca 94086	Approval for the Model 3307 version 4.3a Programmer Software.
P840024/S085 4/2/03 180-Day	Nucleus 22 Cochlear Implant System for Adults	Cochlear Americas Englewood, CO 80112	Approval for the new R126 Version 2 Software and IF6 Card.
P860019/S194 4/1/03 180-Day	Remedy Coronary Balloon Dilatation Infusion Catheter	Boston Scientific Scimed Maple Grove, MN 55311	Approval to manufacture the Remedy Catheter balloon component at Boston Scientific Ireland Limited, Galway, Ireland.
P860057/S021 4/18/03 Special	Carpentier-Edwares® Perimount Plus® Pericardial Bioprosthesis, Model 6900P Mitral	Edwards Lifesciences LLC Irvine, CA 92614	Approval for changes to the warning and precaution information , as well as the instructions for the use of the device.
P870072/S025 4/25/03 Real-Time	Thoratec VAD System; Sealed Arterial Cannulae, 14 mm and 18 mm graft	Thoratec Corporation Pleasanton, CA 94588	Approval for a design modification to the arterial cannulae used with the Thoratec Implantable Ventricular Assist Device.
P880086/S092 4/23/03 180-Day	Application Software Model 3307 (version 4.3a), Bradycardia family of devices: Addvent®, Affinity®, Aurora™, Dialog® II, Entity®, Identity™, Integrity®, Meta™, Microny®, Multilog™, Paragon™, Phoenix®, Quadra™, Reflex®, Regency®, Sensolog® III, Sensorithm™, Simplex™, Solus®, Synchrony®, Tempo™ and Trilogy® families	St. Jude Medical, Inc. Sunnyvale, Ca 94086	Approval for the Model 3307 version 4.3a Programmer Software.
P890027/S054 4/2/03 180-Day	Nucleus 22 Cochlear Implant System for Children	Cochlear Americas Englewood, CO 80112	Approval for the new R126 Version 2 Software and IF6 Card.
P900009/S017 4/22/03 Special	Exogen 2000+ Low Intensity Fracture Healing System	Smith & Nephew, Inc. Memphis, TN 38116	Approval for the addition of a new circuit board inspection step for the Exogen 2000+ device.
P900023/S037 4/28/03 180-Day	Abiomed BVS 5000 Bi-Ventricular Support System	Abiomed, Inc. Danvers, MA 01923	Approval for the addition of the AB5000 pneumatic drive console to the BVS 5000 device system. The AB5000 console can be used to drive one or two BVS 5000 blood pumps; it can be used either in the hospital or for transport of patients between hospitals.
P910023/S065 4/23/03 180-Day	St. Jude Medical™ Epic™ Plus VR/DR Implantable Cardioverter Defibrillators (models V-196 and V-236), Application Software Model 3307 (version 4.3a), Tachycardia family of devices: Angstrom®, Atlas®, Cadet®, Contour®, Epic™, Photon®, Profile™	St. Jude Medical, Inc. Sunnyvale, CA 94086	Approval for the Epic Plus DR/VR device with Model 3307 version 4.3a Programmer Software. The device, as modified, will be marketed under the trade name St. Jude Medical Epic Plus VR/DR Implantable Cardioverter Defibrillators (Models V-196 and V-236) and is indicated 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 indication and sinus node dysfunction. The programmer software Model 3307 version 4.3a supports St. Jude Medical’s Bradycardia and Tachycardia pulse generators.
P920004/S019 4/3/03 180-Day	Vasoseal VHD, ES, Low Profile and Elite Devices	Datascope Corporation Mahway, NJ 07430	Approval to move the remaining chemical processing and textiling operations from the manufacturing facility in Vaals, The Netherlands to Datascope’s facility located in Mahwah, New Jersey.
P920014/S017 4/4/03 180-Day	Thoratec HeartMate® XVE LVAS	Thoratec Corporation Pleasanton, CA 94588	Approval for an expanded indication for use for the Thoratec HeartMate® XVE LVAS. This device system is indicated for use as a bridge to cardiac transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. It is now also indicated for use in patients with New York Heart Association Class IV end stage left ventricular failure who have received optimal medical therapy for at least 60 of the last 90 days, and who have a life expectancy of less than two years, and who are not eligible for cardiac transplantation. The device system is approved for use both inside and outside the hospital.
P920014/S018 4/1/03 180-Day	Thoratec HeartMate® LVAS	Thoratec Corporation Pleasanton, CA 94588	Approval for a manufacturing facility located at Thoratec Corporation, Pleasanton, California.
P940035/S003 4/25/03 180-Day	NMP22® BladderChek™ Kit	Matritech, Inc. Newton, MA 02460	Approval for new test format to be manufactured at Matritech, Inc., Newton, Massachusetts and at a new facility, Unotech Diagnostics, Inc., San Leandro, California. The device, as modified, will be marketed under the trade name NMP22® BladderChek™ Kit and is indicated for the following: The Matritech NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of NMP22 nuclear matrix protein in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer. This test is indicated for professional use and prescription home use as an aid in diagnosing and monitoring bladder cancer patients, in conjunction with standard diagnostic procedures.
P950005/S016 4/22/03 Real-Time	NaviStar™ and Celsius™ Deflectable Tip Diagnostic/Ablation Catheters	Biosense Webster, Inc. Diamond Bar, CA 91765	Approval for changes in the sterilization cycle parameters.
P950020/S007 4/30/03 180-Day	Cutting Balloon Ultra^2™	Boston Scientific – Interventional Technologies	Approval for design changes in the Cutting Balloon, both the Over-the-Wire (OTW) and Monorail (MR) configurations, and for manufacturing changes for the MR configuration. Additionally, approval to add the trade name Cutting Balloon Ultra^2™for both configurations and to add warnings to the Instructions for Use. The device, as modified, will be marketed under the trade name Cutting Balloon Ultra^2™ and is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should posses the following characteristics: discrete (≤ 15 mm in length) or tubular (10 to 20 mm in length); with a reference vessel diameter ranging from 2.0 mm to 4.0 mm; readily accessible to the device; light to moderate tortuosity of proximal vessel segment, non-angulated lesion segment (<45 degrees), smooth angiographic contour; and absence of angiographically-visible thrombus and/or calcification.
P950037/S024 4/23/03 180-Day	Solox VDD Lead Models SLX 58/11-BP, SLX 58/13-BP, SLX 58/14-BP, SLX 58/15-BP, SLX 58/17-BP, SLX 65/11-BP, SLX 65/13-BP, SLX 65/14-BP, SLX 65/15-BP, SLX 65/17-BP	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the Solox VDD pacing Lead. The device, as modified, will be marketed under the trade name Solox VDD Pacing Lead and is indicated as follows: The Solox lead is indicated for use as part of a system only. The system includes any of BIOTRONIK’s VDD dual chamber pulse generators and the Solox VDD lead. Therefore, the indications for the Solox VDD lead are identical to the indications for use of BIOTRONIK’s VDD dual chamber pulse generators. BIOTRONIK’s VDD dual chamber pulse generators are primarily intended to provide VDD pacing for patients with a healthy sinus node. These pulse generators are specifically indicated for patients who need ventricular pacing when adequate atrial rates are present. This includes the presence of complete A-V block when: 1) Atrial contribution is needed for hemodynamic benefit and 2) Pacemaker syndrome had existed or is anticipated. Additional indications include: normal sinus rhythm and normal A-V conductions in patients who intermittently need ventricular pacing support. NOTE: Patients with known paroxysmal atrial fibrillation/flutter may require further evaluation prior to implantation. Other pacing modes are incorporate din the pulse generator (VDDR, VVI, VVIR, VOO, VOOR, VDT, VVT, and VDI) in order to provide clinical flexibility to manage changes in the patient’s condition, for diagnostic purposes, or in the event that VDD pacing becomes inappropriate.
P960022/S003 4/4/03 Real-Time	Bausch & Lomb® SofLens66® Toric (alphafilcon A) Visibility Tinted Contact Lenses	Bausch & Lomb, Inc. Rochester, NY 14609	Approval for a toric design with an extended wear indication from 1 to 7 days between removals for the above referenced device. The device, as modified, will be marketed under the trade name Bausch & Lomb SofLens66 Toric (alphafilconA) Visibility Tinted Contact Lenses and is indicated for extended wear from 1 to 7 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters (D) that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +6.00 D to -9.00D when prescribed for use to 7 days of extended wear.
P960030/S010 4/10/03 Real-Time	IsoFlex™ S Permanent Pacing Lead Models 1642T, 1643K, 1645K, and 1646T	St. Jude Medical, Inc. Sylmar, CA 91342	Approval for reduced lead body size for the Passive Plus DX lead. The device, as modified, will be marketed under the trade name IsoFlex™ S and is indicated for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium (Models 1643K and 1642T) or ventricle (Models 1645K and 1646T).
P960040/S025 4/23/03 180-Day	VITALITY™ Automatic Implantable Cardioverter Defibrillator (AICD) Systems (VITALITY™ DR Model 1871, VITALITY™ VR Model 1870 and VITALITY™ + DR Model 1872), and Model 2857 Software, Version 1.5	Guidant Corporation St. Paul, MN 55112	Approval for VITALITY™ Automatic Implantable Cardioverter Defibrillator (AICD) Systems (VITALITY™ DR Model 1871, VITALITY™ VR Model 1870 and VITALITY™ + DR Model 1872), and Model 2857 Software, Version 1.5. the device is indicated for use in the following: The VITALITY™ AICD system is intended to provide therapy for the automated treatment of life threatening ventricular arrhythmias. Patient populations who are indicated for a Guidant AICD include: 1) Those who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias, or 2) Patients who may benefit from prophylactic treatment due to a prior myocardial infarction and an ejection fraction ≤ 30% (as defined in the MADIT II Clinical Study Appendix).
P960043/S044 4/4/03 Real-Time	Perclose A-T Monofilament 6 Fr. Suture Mediated Closure (SMC) System	Perclose, Inc. Redwood City, CA 94063	Approval to: replace the brained suture with a monofilament polypropylene suture; combine the instructions for use of the Perclose A-T Monofilament 6 Fr. Suture Mediated Closure (SMC) System and the Chito-Seal device into a single pamphlet. The device, as modified, will be marketed under the trade name Perclose A-T Monofilament 6 Fr. Suture Mediated Closure (SMC) System and is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic and interventional catheterization procedures using 5 to 8 Fr. Sheaths. The Perclose A-T Monofilament 6 Fr. SMC System reduces the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic and interventional catheterization procedures without complicating clinical conditions.
P970004/S024 4/1/03 Real-Time	Medtronic InterStim Therapy for Urinary Control (MGU Stim Desktop Application Software to be included on the Medtronic Model 8870 MGU Application Card)	Medtronic, Inc. Shoreview, MN 55126	Approval to limit use of the Model 8870 application card to only the InterStim and Enterra applications by modifying the desktop software, to remove the Model 8529 magnet used with the SynchroMed drug pump application from the programming unit, and to modify the labeling to reflect these changes.
P970008/S021 4/1/03 180-Day	Targis® System	Urologix, Inc. Minneapolis, MN 55447	Approval for modifications to the microwave delivery system (referred to as the “Cooled ThermoCath”) and associated changes to the treatment parameters.
P970035/S039 4/17/03 180-Day	S670 with Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems	Medtronic AVE, Inc. Santa Rosa, CA 95403	Approval to update the labeling of the S670 with Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems to include post-procedure results for the PREDICT study population and remove references to the European RACECAR study.
P970051/S024 4/2/03 180-Day	Nucleus 24 Cochlear Implant System	Cochlear Americas Englewood, CO 80112	Approval for the new R126 Version 2 Software and IF6 Card.
P980033/S006 4/1/03 Special	WALLSTENT® Venous Endoprosthesis with UNISTEP™ Plus Delivery System	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Approval for changes to the Instructions for Use (IFU) manual, namely a modification to the sizing requirements of the introducer sheaths and a modification to the description of the recommended guide wire to be used with the WALLSTENT® Venous Endoprosthesis with UNISTEP™ Plus Delivery System.
P980035/S027 4/16/03 180-Day	AT500 DDDRP Pacing System and Model 9968 Software	Medtronic, Inc. Minneapolis, MN 55432	Approval to move the manufacturing site from Medtronic’s European Operations Center (EOC) in Kerkrade, the Netherlands to Medtronic’s EOC, Heerlen, The Netherlands.
P990025/S006 4/22/03 Real-Time	NaviStar™ and Celsius™ Deflectable Tip Diagnostic/Ablation Catheters	Biosense Webster, Inc. Diamond Bar, CA 91765	Approval for changes in the sterilization cycle parameters (from conventional ethylene oxide processing to EO Express).
P990035/S006 4/24/03 180-Day	Sunlight Omnisense™	Sunlight Medical, Ltd. Rehovot, Israel 76100	Approval for software management module “Sunlight Desktop” (SLD). The device, as modified, will be marketed under the trade name Sunlight Desktop, SLD and is an add-on to the Omnisense software that will function as an independent application. The Sunlight desktop software enables the user to shut down the Omnisense software leaving the PC system operating, so that the user can then initiate any other installed software (per the software manufacturer requirements), which will operate independent of the Omnisense software. This will allow the use of several devices with the control of one PC.
P990065/S001 4/24/03 Special	SIR-Spheres®	Sirtex Medical Ltd. San Diego, CA 92127	Approval for additional warning on the label.
P000015/S004 4/2/03 180-Day	Nucleus 24 Auditory Brainstem Implant	Cochlear Americas Englewood, CO 80112	Approval for the new R126 Version 2 Software and IF6 Card.
P000052/S017 4/9/03 Real-Time	GALILEO® and GALILEO® III Intravascular Radiotherapy Systems	Guidant Corporation Houston, TX 77054	Approval to implement a new software revision, software version 63-0033/M.
P010001/S001 4/4/03 180-Day	Ceramic TRANSCEND® Hip Articulation System	Wright Medical Technology Arlington, TN 38002	Approval for the addition of the LINEAGE™ Acetabular shell to be used with the TRANSCEND® Ceramic Liners.
P010031/S006 4/24/03 180-Day	Insync Marquis Dual Chamber Implantable Cardioverter Defibrillator (Model 7277)	Medtronic, Inc. Fridley, MN 55432	Approval for a manufacturing site located at European Operations Center, Medtronic B.V., Heerlen, The Netherlands. Final device packaging will be performed at this facility.
P010039/S002 4/3/03 180-Day	Siemens Sonocor Basic Extracorporeal Shock Wave Therapy (ESWT) System	Siemens Medical Solutions USA, Inc. Malvern, PA 19355	Approval of the post-approval study for the device. The post-approval study has been submitted to comply with the conditions of approval outlined in the July, 19, 2002 approval order for P010039.
P010040/S002 4/4/03 180-Day	Disintegrator PRO Needle Destruction Device	Safeguard Medical Devices, Inc. Broadview Heights, OH 44147	Approval for clinical use of the device, the components and shielding to minimize EMI levels, a higher current capacity for AC operation and two adapters to accommodate destruction of conventional needles ranging in size from 5/16 to 1 inch in length and 20-30 gauge that are attached to 1 to 3 cc syringes. The device, as modified, which will be marketed under the trade name Disintegrator PRO, is a sharps needle destruction device for clinical use that is indicated for the destruction of lancets and 20 to 30 gauge needles form 5/16 to 1 inch in length.
P010049/S006 4/24/03 Real-Time	QuickSeal II Arterial Closure System	Sub-Q, Inc. San Clemente, CA 92673	Approval to lengthen the approved Guidewire from 55 cm to 70 cm.
P020004/S003 4/22/03 180-Day	Gore EXCLUDER™ Bifurcated Endoprosthesis	W.L. Gore & Associateds, Inc. Flagstaff, AZ 86001	Approval for a change in the packaging and sterilization cycle.
P020014/S003 4/11/03 Special	Essure™ System	Conceptus, Inc. San Carlos, CA 94070	Approval for labeling changes to address the difficulty/failure to disengage or detach the delivery wire from the Essure micro-insert and labeling changes to strengthen the recommendation regarding use of non-steroidal anti-inflammatory drugs (NSAIDs) prior to the Essure procedure.

APPLICATION NUMBER / DATE OF APPROVAL

DEVICE TRADE NAME

COMPANY NAME, CITY, STATE AND ZIP

DEVICE DESCRIPTION / INDICATIONS

N18286/S014

4/21/03

Special

Gelfoam Absorbable Gelatin Sponge

Pharmacia & Upjohn

Kalamazoo, MI

49001

Approval for modified labeling discussing the use of Gelfoam with bovine thrombin.

P830045/S084

4/23/03

180-Day

Application Software Model 3307 (version 4.3a), Bradycardia family of devices: Addvent®, Affinity®, Aurora™,

Dialog® II, Entity®, Identity™, Integrity®, Meta™, Microny®, Multilog™, Paragon™, Phoenix®, Quadra™, Reflex®, Regency®, Sensolog® III, Sensorithm™, Simplex™, Solus®, Synchrony®, Tempo™ and Trilogy® families

St. Jude Medical, Inc.

Sunnyvale, Ca

94086

Approval for the Model 3307 version 4.3a Programmer Software.

P840024/S085

4/2/03

180-Day

Nucleus 22 Cochlear Implant System for Adults

Cochlear Americas

Englewood, CO

80112

Approval for the new R126 Version 2 Software and IF6 Card.

P860019/S194

4/1/03

180-Day

Remedy Coronary

Balloon Dilatation Infusion Catheter

Boston Scientific Scimed

Maple Grove, MN

55311

Approval to manufacture the Remedy Catheter balloon component at Boston Scientific Ireland Limited, Galway, Ireland.

P860057/S021

4/18/03

Special

Carpentier-Edwares® Perimount Plus® Pericardial Bioprosthesis, Model 6900P Mitral

Edwards Lifesciences LLC

Irvine, CA

92614

Approval for changes to the warning and precaution information , as well as the instructions for the use of the device.

P870072/S025

4/25/03

Real-Time

Thoratec VAD System; Sealed Arterial Cannulae, 14 mm and 18 mm graft

Thoratec Corporation

Pleasanton, CA

94588

Approval for a design modification to the arterial cannulae used with the Thoratec Implantable Ventricular Assist Device.

P880086/S092

4/23/03

180-Day

Application Software Model 3307 (version 4.3a), Bradycardia family of devices: Addvent®, Affinity®, Aurora™,

St. Jude Medical, Inc.

Sunnyvale, Ca

94086

Approval for the Model 3307 version 4.3a Programmer Software.

P890027/S054

4/2/03

180-Day

Nucleus 22 Cochlear Implant System for Children

Cochlear Americas

Englewood, CO

80112

Approval for the new R126 Version 2 Software and IF6 Card.

P900009/S017

4/22/03

Special

Exogen 2000+ Low Intensity Fracture Healing System

Smith & Nephew, Inc.

Memphis, TN

38116

Approval for the addition of a new circuit board inspection step for the Exogen 2000+ device.

P900023/S037

4/28/03

180-Day

Abiomed BVS 5000 Bi-Ventricular Support System

Abiomed, Inc.

Danvers, MA

01923

Approval for the addition of the AB5000 pneumatic drive console to the BVS 5000 device system. The AB5000 console can be used to drive one or two BVS 5000 blood pumps; it can be used either in the hospital or for transport of patients between hospitals.

P910023/S065

4/23/03

180-Day

St. Jude Medical™ Epic™ Plus VR/DR Implantable Cardioverter Defibrillators (models V-196 and V-236), Application Software Model 3307 (version 4.3a), Tachycardia family of devices: Angstrom®, Atlas®, Cadet®, Contour®, Epic™, Photon®, Profile™

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for the Epic Plus DR/VR device with Model 3307 version 4.3a Programmer Software. The device, as modified, will be marketed under the trade name St. Jude Medical Epic Plus VR/DR Implantable Cardioverter Defibrillators (Models V-196 and V-236) and is indicated 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 indication and sinus node dysfunction. The programmer software Model 3307 version 4.3a supports St. Jude Medical’s Bradycardia and Tachycardia pulse generators.

P920004/S019

4/3/03

180-Day

Vasoseal VHD, ES, Low Profile and Elite Devices

Datascope Corporation

Mahway, NJ

07430

Approval to move the remaining chemical processing and textiling operations from the manufacturing facility in Vaals, The Netherlands to Datascope’s facility located in Mahwah, New Jersey.

P920014/S017

4/4/03

180-Day

Thoratec HeartMate® XVE LVAS

Thoratec Corporation

Pleasanton, CA

94588

Approval for an expanded indication for use for the Thoratec HeartMate® XVE LVAS. This device system is indicated for use as a bridge to cardiac transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. It is now also indicated for use in patients with New York Heart Association Class IV end stage left ventricular failure who have received optimal medical therapy for at least 60 of the last 90 days, and who have a life expectancy of less than two years, and who are not eligible for cardiac transplantation. The device system is approved for use both inside and outside the hospital.

P920014/S018

4/1/03

180-Day

Thoratec HeartMate® LVAS

Thoratec Corporation

Pleasanton, CA

94588

Approval for a manufacturing facility located at Thoratec Corporation, Pleasanton, California.

P940035/S003

4/25/03

180-Day

NMP22® BladderChek™ Kit

Matritech, Inc.

Newton, MA

02460

Approval for new test format to be manufactured at Matritech, Inc., Newton, Massachusetts and at a new facility, Unotech Diagnostics, Inc., San Leandro, California. The device, as modified, will be marketed under the trade name NMP22® BladderChek™ Kit and is indicated for the following: The Matritech NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of NMP22 nuclear matrix protein in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer. This test is indicated for professional use and prescription home use as an aid in diagnosing and monitoring bladder cancer patients, in conjunction with standard diagnostic procedures.

P950005/S016

4/22/03

Real-Time

NaviStar™ and Celsius™ Deflectable Tip Diagnostic/Ablation Catheters

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for changes in the sterilization cycle parameters.

P950020/S007

4/30/03

180-Day

Cutting Balloon Ultra^2™

Boston Scientific – Interventional Technologies

Approval for design changes in the Cutting Balloon, both the Over-the-Wire (OTW) and Monorail (MR) configurations, and for manufacturing changes for the MR configuration. Additionally, approval to add the trade name Cutting Balloon Ultra^2™for both configurations and to add warnings to the Instructions for Use. The device, as modified, will be marketed under the trade name Cutting Balloon Ultra^2™ and is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should posses the following characteristics: discrete (≤ 15 mm in length) or tubular (10 to 20 mm in length); with a reference vessel diameter ranging from 2.0 mm to 4.0 mm; readily accessible to the device; light to moderate tortuosity of proximal vessel segment, non-angulated lesion segment (<45 degrees), smooth angiographic contour; and absence of angiographically-visible thrombus and/or calcification.

P950037/S024

4/23/03

180-Day

Solox VDD Lead Models SLX 58/11-BP, SLX 58/13-BP, SLX 58/14-BP, SLX 58/15-BP, SLX 58/17-BP, SLX 65/11-BP, SLX 65/13-BP, SLX 65/14-BP, SLX 65/15-BP, SLX 65/17-BP

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the Solox VDD pacing Lead. The device, as modified, will be marketed under the trade name Solox VDD Pacing Lead and is indicated as follows: The Solox lead is indicated for use as part of a system only. The system includes any of BIOTRONIK’s VDD dual chamber pulse generators and the Solox VDD lead. Therefore, the indications for the Solox VDD lead are identical to the indications for use of BIOTRONIK’s VDD dual chamber pulse generators. BIOTRONIK’s VDD dual chamber pulse generators are primarily intended to provide VDD pacing for patients with a healthy sinus node. These pulse generators are specifically indicated for patients who need ventricular pacing when adequate atrial rates are present. This includes the presence of complete A-V block when: 1) Atrial contribution is needed for hemodynamic benefit and 2) Pacemaker syndrome had existed or is anticipated. Additional indications include: normal sinus rhythm and normal A-V conductions in patients who intermittently need ventricular pacing support. NOTE: Patients with known paroxysmal atrial fibrillation/flutter may require further evaluation prior to implantation. Other pacing modes are incorporate din the pulse generator (VDDR, VVI, VVIR, VOO, VOOR, VDT, VVT, and VDI) in order to provide clinical flexibility to manage changes in the patient’s condition, for diagnostic purposes, or in the event that VDD pacing becomes inappropriate.

P960022/S003

4/4/03

Real-Time

Bausch & Lomb® SofLens66® Toric (alphafilcon A) Visibility Tinted Contact Lenses

Bausch & Lomb, Inc.

Rochester, NY

14609

Approval for a toric design with an extended wear indication from 1 to 7 days between removals for the above referenced device. The device, as modified, will be marketed under the trade name Bausch & Lomb SofLens66 Toric (alphafilconA) Visibility Tinted Contact Lenses and is indicated for extended wear from 1 to 7 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters (D) that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +6.00 D to -9.00D when prescribed for use to 7 days of extended wear.

P960030/S010

4/10/03

Real-Time

IsoFlex™ S Permanent Pacing Lead Models 1642T, 1643K, 1645K, and 1646T

St. Jude Medical, Inc.

Sylmar, CA

91342

Approval for reduced lead body size for the Passive Plus DX lead. The device, as modified, will be marketed under the trade name IsoFlex™ S and is indicated for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium (Models 1643K and 1642T) or ventricle (Models 1645K and 1646T).

P960040/S025

4/23/03

180-Day

VITALITY™ Automatic Implantable Cardioverter Defibrillator (AICD) Systems (VITALITY™ DR Model 1871, VITALITY™ VR Model 1870 and VITALITY™ + DR Model 1872), and Model 2857 Software, Version 1.5

Guidant Corporation

St. Paul, MN

55112

Approval for VITALITY™ Automatic Implantable Cardioverter Defibrillator (AICD) Systems (VITALITY™ DR Model 1871, VITALITY™ VR Model 1870 and VITALITY™ + DR Model 1872), and Model 2857 Software, Version 1.5. the device is indicated for use in the following: The VITALITY™ AICD system is intended to provide therapy for the automated treatment of life threatening ventricular arrhythmias. Patient populations who are indicated for a Guidant AICD include: 1) Those who have had spontaneous and/or inducible life-threatening ventricular arrhythmias and those who are at high risk for developing such arrhythmias, or 2) Patients who may benefit from prophylactic treatment due to a prior myocardial infarction and an ejection fraction ≤ 30% (as defined in the MADIT II Clinical Study Appendix).

P960043/S044

4/4/03

Real-Time

Perclose A-T Monofilament 6 Fr. Suture Mediated Closure (SMC) System

Perclose, Inc.

Redwood City, CA

94063

Approval to: replace the brained suture with a monofilament polypropylene suture; combine the instructions for use of the Perclose A-T Monofilament 6 Fr. Suture Mediated Closure (SMC) System and the Chito-Seal device into a single pamphlet. The device, as modified, will be marketed under the trade name Perclose A-T Monofilament 6 Fr. Suture Mediated Closure (SMC) System and is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic and interventional catheterization procedures using 5 to 8 Fr. Sheaths. The Perclose A-T Monofilament 6 Fr. SMC System reduces the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic and interventional catheterization procedures without complicating clinical conditions.

P970004/S024

4/1/03

Real-Time

Medtronic InterStim Therapy for Urinary Control (MGU Stim Desktop Application Software to be included on the Medtronic Model 8870 MGU Application Card)

Medtronic, Inc.

Shoreview, MN

55126

Approval to limit use of the Model 8870 application card to only the InterStim and Enterra applications by modifying the desktop software, to remove the Model 8529 magnet used with the SynchroMed drug pump application from the programming unit, and to modify the labeling to reflect these changes.

P970008/S021

4/1/03

180-Day

Targis® System

Urologix, Inc.

Minneapolis, MN

55447

Approval for modifications to the microwave delivery system (referred to as the “Cooled ThermoCath”) and associated changes to the treatment parameters.

P970035/S039

4/17/03

180-Day

S670 with Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Approval to update the labeling of the S670 with Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems to include post-procedure results for the PREDICT study population and remove references to the European RACECAR study.

P970051/S024

4/2/03

180-Day

Nucleus 24 Cochlear Implant System

Cochlear Americas

Englewood, CO

80112

Approval for the new R126 Version 2 Software and IF6 Card.

P980033/S006

4/1/03

Special

WALLSTENT® Venous Endoprosthesis with UNISTEP™ Plus Delivery System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for changes to the Instructions for Use (IFU) manual, namely a modification to the sizing requirements of the introducer sheaths and a modification to the description of the recommended guide wire to be used with the WALLSTENT® Venous Endoprosthesis with UNISTEP™ Plus Delivery System.

P980035/S027

4/16/03

180-Day

AT500 DDDRP Pacing System and Model 9968 Software

Medtronic, Inc.

Minneapolis, MN

55432

Approval to move the manufacturing site from Medtronic’s European Operations Center (EOC) in Kerkrade, the Netherlands to Medtronic’s EOC, Heerlen, The Netherlands.

P990025/S006

4/22/03

Real-Time

NaviStar™ and Celsius™ Deflectable Tip Diagnostic/Ablation Catheters

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for changes in the sterilization cycle parameters (from conventional ethylene oxide processing to EO Express).

P990035/S006

4/24/03

180-Day

Sunlight Omnisense™

Sunlight Medical, Ltd.

Rehovot, Israel

76100

Approval for software management module “Sunlight Desktop” (SLD). The device, as modified, will be marketed under the trade name Sunlight Desktop, SLD and is an add-on to the Omnisense software that will function as an independent application. The Sunlight desktop software enables the user to shut down the Omnisense software leaving the PC system operating, so that the user can then initiate any other installed software (per the software manufacturer requirements), which will operate independent of the Omnisense software. This will allow the use of several devices with the control of one PC.

P990065/S001

4/24/03

Special

SIR-Spheres®

Sirtex Medical Ltd.

San Diego, CA

92127

Approval for additional warning on the label.

P000015/S004

4/2/03

180-Day

Nucleus 24 Auditory Brainstem Implant

Cochlear Americas

Englewood, CO

80112

Approval for the new R126 Version 2 Software and IF6 Card.

P000052/S017

4/9/03

Real-Time

GALILEO® and GALILEO® III Intravascular Radiotherapy Systems

Guidant Corporation

Houston, TX

77054

Approval to implement a new software revision, software version 63-0033/M.

P010001/S001

4/4/03

180-Day

Ceramic TRANSCEND® Hip Articulation System

Wright Medical Technology

Arlington, TN

38002

Approval for the addition of the LINEAGE™ Acetabular shell to be used with the TRANSCEND® Ceramic Liners.

P010031/S006

4/24/03

180-Day

Insync Marquis Dual Chamber Implantable Cardioverter Defibrillator (Model 7277)

Medtronic, Inc.

Fridley, MN

55432

Approval for a manufacturing site located at European Operations Center, Medtronic B.V., Heerlen, The Netherlands. Final device packaging will be performed at this facility.

P010039/S002

4/3/03

180-Day

Siemens Sonocor Basic Extracorporeal Shock Wave Therapy (ESWT) System

Siemens Medical Solutions USA, Inc.

Malvern, PA

19355

Approval of the post-approval study for the device. The post-approval study has been submitted to comply with the conditions of approval outlined in the July, 19, 2002 approval order for P010039.

P010040/S002

4/4/03

180-Day

Disintegrator PRO Needle Destruction Device

Safeguard Medical Devices, Inc.

Broadview Heights, OH

44147

Approval for clinical use of the device, the components and shielding to minimize EMI levels, a higher current capacity for AC operation and two adapters to accommodate destruction of conventional needles ranging in size from 5/16 to 1 inch in length and 20-30 gauge that are attached to 1 to 3 cc syringes. The device, as modified, which will be marketed under the trade name Disintegrator PRO, is a sharps needle destruction device for clinical use that is indicated for the destruction of lancets and 20 to 30 gauge needles form 5/16 to 1 inch in length.

P010049/S006

4/24/03

Real-Time

QuickSeal II Arterial Closure System

Sub-Q, Inc.

San Clemente, CA

92673

Approval to lengthen the approved Guidewire from 55 cm to 70 cm.

P020004/S003

4/22/03

180-Day

Gore EXCLUDER™ Bifurcated Endoprosthesis

W.L. Gore & Associateds, Inc.

Flagstaff, AZ

86001

Approval for a change in the packaging and sterilization cycle.

P020014/S003

4/11/03

Special

Essure™ System

Conceptus, Inc.

San Carlos, CA

94070

Approval for labeling changes to address the difficulty/failure to disengage or detach the delivery wire from the Essure micro-insert and labeling changes to strengthen the recommendation regarding use of non-steroidal anti-inflammatory drugs (NSAIDs) prior to the Essure procedure.

APPLICATION NUMBER / DATE OF APPROVAL	DEVICE TRADE NAME	COMPANY NAME, CITY, STATE AND ZIP	DEVICE DESCRIPTION / INDICATIONS
P830061/S036 4/3/03	CapSure and Sprint Families of Leads	Medtronic, Inc. Minneapolis, MN 55432	Addition of an alternate supplier of polyetherurethane.
P850089/S052 4/3/03	CapSure and Sprint Families of Leads	Medtronic, Inc. Minneapolis, MN 55432	Addition of an alternate supplier of polyetherurethane.
P860047/S012 4/16/03	Ocucoat (2% Hydroxypropyl-methylcellulose Solution)	Bausch & Lomb San Dimas, CA 91773	Change in the frequency of the following incoming inspection tests: HPMC content, total chlorides, osmolarity, particulates, protein, density, HPMC volume, pH and viscosity.
P920015/S027 4/3/03	CapSure and Sprint Families of Leads	Medtronic, Inc. Minneapolis, MN 55432	Addition of an alternate supplier of polyetherurethane.
P930039/S015 4/3/03	CapSure and Sprint Families of Leads	Medtronic, Inc. Minneapolis, MN 55432	Addition of an alternate supplier of polyetherurethane.
P950034/S024 4/25/03	Seprafilm® Adhesion Barrier and Seprafilm Procedure Pack	Genzyme Corporation Cambridge, MA 02142	Manufacturing change by the addition of an alternate raw material supplier of Hyaluronic Acid (HA).
P980016/S034 4/3/03	CapSure and Sprint Families of Leads	Medtronic, Inc. Minneapolis, MN 55432	Addition of an alternate supplier of polyetherurethane.
P010021/S001 4/30/03	Vitros® Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator	Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626	Additional raw material supplier for uncoated microwells. The additional supplier will be Tech Group Ireland.

APPLICATION NUMBER / DATE OF APPROVAL

DEVICE TRADE NAME

COMPANY NAME, CITY, STATE AND ZIP

DEVICE DESCRIPTION / INDICATIONS

P830061/S036

4/3/03

CapSure and Sprint Families of Leads

Medtronic, Inc.

Minneapolis, MN

55432

Addition of an alternate supplier of polyetherurethane.

P850089/S052

4/3/03

CapSure and Sprint Families of Leads

Medtronic, Inc.

Minneapolis, MN

55432

Addition of an alternate supplier of polyetherurethane.

P860047/S012

4/16/03

Ocucoat (2% Hydroxypropyl-methylcellulose Solution)

Bausch & Lomb

San Dimas, CA

91773

Change in the frequency of the following incoming inspection tests: HPMC content, total chlorides, osmolarity, particulates, protein, density, HPMC volume, pH and viscosity.

P920015/S027

4/3/03

CapSure and Sprint Families of Leads

Medtronic, Inc.

Minneapolis, MN

55432

Addition of an alternate supplier of polyetherurethane.

P930039/S015

4/3/03

CapSure and Sprint Families of Leads

Medtronic, Inc.

Minneapolis, MN

55432

Addition of an alternate supplier of polyetherurethane.

P950034/S024

4/25/03

Seprafilm® Adhesion Barrier and Seprafilm Procedure Pack

Genzyme Corporation

Cambridge, MA

02142

Manufacturing change by the addition of an alternate raw material supplier of Hyaluronic Acid (HA).

P980016/S034

4/3/03

CapSure and Sprint Families of Leads

Medtronic, Inc.

Minneapolis, MN

55432

Addition of an alternate supplier of polyetherurethane.

P010021/S001

4/30/03

Vitros® Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Additional raw material supplier for uncoated microwells. The additional supplier will be Tech Group Ireland.

PMA Final Decisions Rendered for April 2003

PMA Original Approvals