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PMA Final Decisions Rendered for December 2001

P000039

12/5/01

AMPLATZER® Septal Occluder (ASO) and the AMPLATZER® Exchange System

AGA Medical Corporation

Golden Valley, MN

55427

Approval for the AMPLATZER® Septal Occluder (ASO) and the AMPLATZER® Exchange System.  The AMPLATZER® Septal Occluder (ASO) device is indicated for the occlusion of atrial septal defects (ASD) in secundum position.  The ASO device is also indicated in patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration.  Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (i.e., 1.5:1 degree of left to right shunt or RV enlargement).  The AMPLATZER® Exchange system is intended for the removal of an AMPLATZER® Delivery Sheath and subsequent exchange for an AMPLATZER® Delivery Sheath of equal or larger diameter.

P000049

12/5/01

CardioSEAL® Septal Occlusion System with QwikLoad™

Nitinol Medical Technologies, Inc.

Boston, MA

02210

Approval for the CardioSEAL® Septal Occlusion System with QwikLoad™.  The system is indicated for use in patients with complex ventricular septal defects (VSD) of significant size to warrant closure who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.  High risk anatomical factors for transatrial or transarterial surgical closure include patients:  1) requiring a left ventriculotomy or an extensive right ventriculotomy;  2) with a failed previous VSD closure;  3) with multiple apical and/or anterior muscular VSDs (“Swiss Cheese Septum”); or  4) with posterior apical VSDs covered by trabeculae.

P010003

12/3/01

BioGlue® Surgical Adhesive

CryoLife, Inc.

Kennesaw, GA

30144

Approval for the BioGlue® Surgical Adhesive.  This device is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral and carotid arteries).

P010020

12/18/01

AMS Acticon™ Neosphincter

American Medical Systems

Minnetonka, MN

55343

Approval for the AMS Acticon™ Neosphincter system.  This device is indicated to treat severe fecal incontinence in males and females eighteen years and older who have failed, or are not candidates for, less invasive forms of restorative therapy.

P010022

12/14/01

CoSeal™ Surgical Sealant

Cohesion Technologies, Inc.

Palo Alto, CA

94303

Approval for the CoSeal™ Surgical Sealant.  This device is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

P010030

12/18/01

WCD® 2000 System

Lifecor, Inc.

Pittsburgh, PA

15238

Approval for the WCD® 2000 System.  This device is indicated for adult patients who are at risk for sudden cardiac arrest and either are not candidates for or refuse an implantable defibrillator.

N17600/S019

12/6/01

Real-Time

Avitene® UltraWrap™ Collagen Hemostat

Davol, Inc.

Cranston, RI

02920

Approval for manufacturing modifications to the Avitene® UltraFoam™ Cast Microfibrillar Collagen Hemostat (MCH) Sponge and modifications to the labeling.  The device, as modified, will be marketed under the trade name Avitene® UltraWrap™ Collagen Hemostat and is indicated for use in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

P790017/S073

12/21/01

180-Day

Neptune TM X-act and Neptune TM X-act Duo OTW Balloon Dilatation Catheter

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Approval to change the supplier of the polyethylene terephthlate (PET) Alloy Balloon Tubing used in the manufacturing of the devices.

P790018/S038

12/11/01

Special

Medtronic Hall Heart Valves A7700 and M7700

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of an ethylene oxide gas concentration monitor to a parametric release sterilization process.

P790018/S039

12/11/01

180-Day

Medtronic Hall Prosthetic Heart Valve (Models A7700 and M7700)

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a new manufacturing facility located at Medtronic, Inc., Spring Lake Park, Minnesota.

P820021/S030

12/12/01

180-Day

Softcon® (vifilcon A) Soft (hydrophilic) Contact Lens for Extended Wear

CIBA Vision Corporation

Duluth, GA

30097

Approval for an additional manufacturing facility located at CIBA Vision Corporation, Cidra, Puerto Rico.

P830045/S080

12/21/01

Real-Time

Atlas™ Implantable Cardioverter Defibrillator System with Model 3307 Programmer Software, version 3.1

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for the Atlas™ DR/VR (Models V-240 and V-199) Implantable Cardioverter Defibrillator System with Model 3307 Programmer Software version 3.1.  These devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life-threatening ventricular arrhythmias.

P830061/S033

12/11/01

Special

CapSure Family of Leads/Accessories

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of an ethylene oxide gas concentration monitor to a parametric release sterilization process.

P840001/S058

12/14/01

Real-Time

Model 7427V Synergy Versitrel Dual Channel Implantable Pulse Generator

Medtronic, Inc.

Minneapolis, MN

55421

Approval for the Model 7427V Synergy Versitrel Dual Channel Implantable Pulse Generator and is indicated as an aid in the management of chronic, intractable pain of the trunk or limbs.

P840001/S059

12/11/01

Special

Medtronic Spinal Cord Stimulation System

Medtronic, Inc.

Minneapolis, MN

55421

Approval for a change to the manufacturing process to include an additional method for monitoring ethylene gas concentrations during the sterilization process.

P850089/S049

12/11/01

Special

CapSure and CapSure Novus Families of Leads/Accessories

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of an ethylene oxide gas concentration monitor to a parametric release sterilization process.

P850089/S050

12/19/01

Real-Time

Medtronic CapSure SP Model 5024M and SureFix Model 5072 Leads

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the following:  1) a change in outer insulation treatment from silacure to siloxane for the CapSure SP Model 5024M Lead;  2) a material change from MDX silicone to MED 4719 silicone for SureFix Model 5072 inner and outer insulation (outer insulation with siloxane treatment); and  3) associated minor labeling changes.

P860004/S048

12/5/01

Special

SynchroMed Programmable Infusion Pumps

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of an ethylene oxide gas concentration monitor to a parametric release sterilization process.

P880086/S087

12/21/01

Real-Time

Atlas™ Implantable Cardioverter Defibrillator System with Model 3307 Programmer Software, version 3.1

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for the Atlas™ DR/VR (Models V-240 and V-199) Implantable Cardioverter Defibrillator System with Model 3307 Programmer Software version 3.1.  These devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life-threatening ventricular arrhythmias.

P890003/S066

12/11/01

Special

Thera/Thera-I Family of Pulse Generators

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of an ethylene oxide gas concentration monitor to a parametric release sterilization process.

P890043/S037

12/5/01

Real-Time

FLEXI-CUT™ Directional Debulking System

Guidant Corporation

Temecula, CA

92591

Approval for labeling changes for the FLEXI-CUT™ Directional Debulking System.  The labeling changes include the addition of a summary of the Physician preference Testing information, and the addition of a warning statement  to remove atheromatous tissue from the nosecone frequently to avoid guidewire restriction.

P900061/S051

12/11/01

Special

Gem Family of ICD/

Pulse Generators

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of an ethylene oxide gas concentration monitor to a parametric release sterilization process.

P910023/S058

12/21/01

Real-Time

Atlas™ Implantable Cardioverter Defibrillator System with Model 3307 Programmer Software, version 3.1

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for the Atlas™ DR/VR (Models V-240 and V-199) Implantable Cardioverter Defibrillator System with Model 3307 Programmer Software version 3.1.  These devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life-threatening ventricular arrhythmias.

P920015/S025

12/11/01

Special

Sprint Family of Leads

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of an ethylene oxide gas concentration monitor to a parametric release sterilization process.

P930039/S012

12/11/01

Special

CapSureFix Family of Leads

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of an ethylene oxide gas concentration monitor to a parametric release sterilization process.

P930039/S013

12/19/01

Real-Time

Medtronic CapSure SP Model 5024M and SureFix Model 5072 Leads

Medtronic, Inc.

Minneapolic, MN

55432

Approval for the following:  1) a change in outer insulation treatment from silacure to siloxane for the CapSure SP Model 5024M Lead;  2) a material change from MDX silicone to MED 4719 silicone for SureFix Model 5072 inner and outer insulation (outer insulation with siloxane treatment); and  3) associated minor labeling changes.

P950024/S005

12/11/01

Special

CapSureEpi Family of Leads

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of an ethylene oxide gas concentration monitor to a parametric release sterilization process.

P960004/S020

12/18/01

Real-Time

FINELINE II Sterox Leads

Guidant Corporation

St. Paul, MN

55112

Approval for use of Dexamethasone Acetate (DXA) as an alternate steroid collar on the FINELINE II Sterox Lead Models 4456, 4457, 4458, 4459, 4469, 4470, 4471, 4472, 4473, 4479 and 4480.

P960007/S016

12/26/01

Real-Time

TRANSCYTE®, Human Fibroblast-Derived Temporary Skin Substitute

Advanced Tissue Sciences

La Jolla, CA

92037

Approval for the ceasing of enrollment of new patients in the post-market approval study: TC-01-07-0597 “An Open Label Study to Evaluate the Incidence of Wound Infection in Patients Requiring a Temporary Covering for Excised Burn Wounds”

P960009/S019

12/31/01

180-Day

Medtronic Activa® Tremor Control System

Medtronic, Inc.

Minneapolis, MN

55421

Approval for the Model 7438 Therapy Controller which is intended to be used as an alternative to the existing Model 7452 Control Magnet as a component of the Medtronic Activa Tremor Control System.

P960009/S022

12/11/01

Special

Medtronic Activa® Tremor Control System

Medtronic, Inc.

Minneapolis, MN

55421

Approval for a change to the manufacturing process to include an additional method for monitoring ethylene gas concentrations during the sterilization process.

P960043/S035

12/28/01

Real-Time

Closer II 6Fr. Suture-Mediated Closure (SMC) System

Perclose, Inc.

Redwood City, CA

94063

Approval for a modification of the Closer S™ Suture-Mediated Closure (SMC) device to allow for a pre-tied knot upon device use.  The device, as modified, will be marketed under the trade name Closer II 6Fr. 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 6 Fr. Sheaths.  The Closer II 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/S018

12/5/01

Special

Medtronic® InterStim® Therapy for Urinary Control

Neurological – Functional Stimulation

Minneapolis, MN

55421

Approval for adding an additional method for monitoring ethylene oxide gas concentrations during the sterilization process.

P970008/S015

12/6/01

180-Day

Urologix Targis System

Urologix, Inc.

Minneapolis, MN

55447

Approval for a manufacturing site located at Colorado MedTech, Inc., Longmont, Colorado.

P970008/S016

12/6/01

180-Day

Urologix Targis System

Urologix, inc.

Minneapolis, MN

55447

Approval for a manufacturing site located at Urologix, Inc., Minneapolis, Minneapolis.

P970012/S012

12/11/01

Special

Kappa 400 Family of Pulse Generators

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of an ethylene oxide gas concentration monitor to a parametric release sterilization process.

P970034/S008

12/31/01

180-Day

Model UB55AC Posterior Chamber Intraocular Lens

Ophthalmic Innovations International, Inc.

Ontario, CA

91761

Approval for Model UB55AC Posterior Chamber Intraocular Lens.

P980016/S021

12/21/01

180-Day

Model 2490A CareLink Monitor with Model 2491 DDMA Server-Resident Software

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Model 2490A CareLink Monitor with Model 2491 DDMA Server-Resident Software.  The device, as modified, will be marketed under the trade name Model 2490A CareLink Monitor and is indicated for use in the transfer of patient data from Medtronic GEM II ICDs (GEM II VR Model 7229 and GEM II DR Model 7273).

P980016/S024

12/11/01

Special

Gem II Family of ICD/

Pulse Generators

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of an ethylene oxide gas concentration monitor to a parametric release sterilization process.

P980024/S001

12/31/01

Panel

PathVysion™  HER-2 DNA Probe Kit

Vysis, Inc.

Downers Grove, IL

60515

Approval for the PathVysion™ HER-2 DNA Probe Kit.  This device is indicated to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens.  Results from the PathVysion™ Kit are intended for use as an adjunct to existing clinical and pathologic information currently used as prognostic factors in stage II, node-positive breast cancer patients.  The PathVysion™ Kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) chemotherapy.  The PathVysion™ Kit is indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered (see HERCEPTIN® package insert).

P980035/S014

12/14/01

Real-Time

Medtronic Kappa™ 900/800 Pacemaker Series and Model 9988 Software Series 1.1

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic Kappa™ 900/800 Pacemaker Series Models K(DR)901, K(DR)903, K(DR)906, K(DR)921, K(DR)931, K(DR)933, K(DR)801, K(DR)803, K(DR)806, K(D)901, K(D)903, K(D)906, KVDD901, KSR901, KSR903, and KSR906 and Model 9988 Software Series 1.1.  The devices are indicated for the following:  1) Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity.  2) Accepted patient conditions warranting chronic cardiac pacing which include: 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; and e) Vasovagal syndromes or hypersensitive carotid sinus syndromes.  3) Medtronic Kappa™ 900/800 Series pacemakers are also indicated for dual chamber and atrial tracking modes in patients 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: a) Various degrees of AV block to maintain the atrial contribution to cardiac output; and b) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.  4)  Medtronic Kappa 900/800 Series pacemakers are also indicated for VDD pacing in patients having adequate atrial rates and the following indications: a) Requirements for ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present.  This includes the presence of complete AV block when atrial contribution is needed for hemodynamic benefit or when pacemaker syndrome has existed or is anticipated. b) Normal sinus rhythm and normal AV conduction in patients needing ventricular pacing intermittently.

P980035/S016

12/11/01

Special

Kappa 700/600, Sigma and 350 Series Families of Pulse Generators

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of an ethylene oxide gas concentration monitor to a parametric release sterilization process.

P980049/S006

12/21/01

Real-Time

Alto ICD Models 614 and 615

ELA Medical, LLC

Plymouth, MN

55441

Approval for Alto ICD Models 614 and 615.  The device, as modified, will be marketed under the trade name Alto DR Model 614 ICD and Alto VR Model 615, and is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations:  1) survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia;  2) recurrent, poorly tolerated, sustained ventricular tachycardia (VT).  Note: The clinical outcome for hemodynamically stable VT patients is not fully known.  Safety and effectiveness studies have not been conducted.

P980050/S010

12/11/01

Special

Gem III AT Model 7276 ICD/

Pulse Generators

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of an ethylene oxide gas concentration monitor to a parametric release sterilization process.

P990001/S010

12/11/01

Special

Dema and Diva Families of Pulse Generators

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of an ethylene oxide gas concentration monitor to a parametric release sterilization process.

P990017/S028

12/17/01

180-Day

ANCURE® Endograft® System

Guidant Corporation

Menlo Park, CA

94025

Approval for changes in the manufacturing process of the Contralateral Pull Wire.

P990017/S029

12/11/01

Special

Ancure® Endograft® System for the treatment of Abdominal Aortic Aneurysms

Guidant Corporation

Menlo Park, CA

94025

Approval for temporary addition of a label to inspect the contralateral cutter packaged with the ANCURE device.  The change would apply to 436 devices manufactured between October 12, 2001 and November 12, 2001.

P990030/S002

12/21/01

Special

CoStasis®/ DynaStat™ Surgical Hemostats

Cohesion Technologies

Palo Alto, CA

94303

Approval for modifications to the CoStasis®/DynaStat™ Surgical Hemostats’ product labeling.

P990037/S007

12/31/01

Special

Vascular Solutions Duett™ Sealing

Device

Vascular Solutions, Inc.

Minneapolis, MN

55441

Approval for labeling changes in the instructions for use that stratifies adverse events into Diagnostic and Interventional patient populations.

P990053/S002

12/19/01

180-Day

OxiFirst™ Fetal Sensor FS14-Series

Tyco Healthcare Group

Pleasanton, CA

94588

Approval for an alternate manufacturing facility located at Tyco Healthcare Group, Tijuana, Mexico.

P990055/S001

12/7/01

180-Day

Bayer ACS:180 or Advia Centaur Complex PSA Assays

Bayer Corporation

Tarrytown, NY

10591

Approval for the addition of the assay to the Bayer ACS:180® and ADVIA Centaur® analyzers.  The device, as modified, will be marketed under the trade names Bayer ACS:180 or ADVIA Centaur complexed PSA assay and are indicated as follows:  This In Vitro device is intended to quantitatively measure complexed prostate-specific antigen (cPSA) in human serum using the Bayer Diagnostics Immuno 1™, the ACS:180® System, or the ADVIA Centaur® System.  This device is indicated for the measurement of serum complexed PSA in conjunction with digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older.

P990066/S004

12/6/01

180-Day

Senographe 2000D Full Field Digital Mammography System

General Electric Medical Systems

Milwaukee, WI

53201

Approval for changes to the image chain software, specifically the Automatic Operating Parameters (AOP) and the Auto-Contrast and Thickness Compensation algorithms; the addition of some new features to the Acquisition Work Station and the Review Work Station that provide more options for image display and printing; and revised labeling to address the changes.

P990066/S008

12/18/01

Real-Time

Mobile Senographe 2000D

General Electric Medical Systems

Milwaukee, WI

53201

Approval to make a mobile version of the device, that is capable of moving from place to place in an air-ride van and able to transmit images from these locations via a wireless communications link.

P990066/S010

12/3/01

180-Day

Senographe 2000D Full Field Digital Mammography System

General Electric Medical Systems

Milwaukee, WI

53201

Approval for a modified Control Console including minor hardware and software modifications to the approved system.  The supplement also includes appropriate changes in the labeling to reflect these changes.

P000011/S003

12/21/01

180-Day

Phosphorylcholine (PC) coated BiodivYsio™ SV stent premounted on an Over-the-Wire (OTW) delivery system (BiodivYsio™ SV OTW), and PC coated BiodivYsio™ AS stent premounted on an Over-the-Wire (OTW) delivery system (BiodivYsio™ AS OTW)

Biocompatibles Cardiovascular, Inc.

San Jose, CA

95113

Approval for the following:  1) The BiodivYsio™ SV OTW in 10 mm, 15 mm and 18 mm stent lengths and 2.0 mm and 2.5 mm diameters.  The device, as modified, will be marketed under the trade name BiodivYsio™ SV OTW and is indicated for “improving coronary luminal diameter in subjects experiencing abrupt closure or threatened abrupt vessel closure following percutaneous revascularization of de novo or non in-stent restenotic native coronary artery lesions (length of lesion and/or dissection ≤ 25 mm) with a reference vessel diameter ranging from ≥ 2.0 mm to ≤ 3.0 mm by visual estimate.  Long-term outcome (beyond 6 months) for this implant is unknown at present.  2) The BiodivYsio™ AS OTW in 11 mm and 15 mm stent lengths and 3.0 mm, 3.5 mm and 4.0 mm diameters.  The device, as modified, will be marketed under the trade name BiodivYsio AS OTW and is indicated for improving coronary luminal diameter in the following:  a) subjects with symptomatic ischemic heart disease due to de novo native coronary artery lesions (length ≤ 25 mm) with a reference vessel diameter ranging from ≥ 3.0 mm to ≤ 4.0 mm;  and  b) subjects experiencing abrupt closure or threatened abrupt vessel closure following percutaneous revascularization of de novo or non in-stent restenotic native coronary artery lesions (length of lesion and/or dissection ≤ 25 mm) with a reference vessel diameter ranging from ≥ 3.0 mm to ≤ 4.0 mm by visual estimation.  Long term outcome (beyond 6 months) for these permanent implants are unknown at present.

P000040/S002

12/7/01

180-Day

Hydro ThermAblator® Endometrial Ablation System

BEI Medical Systems

Teterboro, NJ

07608

Approval for using molding and extruding techniques rather than machining the components that make up the disposable sheath of the Hydro ThermAblator® Endometrial Ablation System.

P000052/S003

12/17/01

180-Day

GALILEO™ Intravascular Radiotherapy System

Guidant Corporation

Houston, TX

77054

Approval for an alternate white foil material for use as Femoral and Brachial markers on the centering catheter.

P010015/S002

12/11/01

Special

InSync IPG Model 8040 Biventricular Pulse Generator System

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of an ethylene oxide gas concentration monitor to a parametric release sterilization process.

P010016/S001

12/6/01

Real-Time

OrCel Bilayered Cellular Matrix

Ortec International, Inc.

New York, NY

10032

Approval for the use of cell lines FS-143 and FS-145 in the commercial manufacture of OrCel Bilayered Cellular Matrix.

P790018/S040

12/19/01

Medtronic Hall™ Prosthetic Heart Valve, Models A7700 and M7700 and Hall Easy-Fit™ Prosthetic Heart Valve, Models A7700 an dM7700

Medtronic Heart Valves

Minneapolis, MN

55432

Addition of an alternate steam (autoclave) sterilizer with a change in sterilization time form 24 to 40 minutes.

P860064/S010

12/7/01

DuPen®

Long-Term Epidural Catheter

Bard Access Systems, Inc.

Salt Lake City, UT

84116

Manufacturing change in EtO sterilization cycle parameters.

P920047/S016

12/18/01

EPT-1000 Cardiac Ablation System

EP Technologies, Inc.

San Jose, CA

95134

Use of a current vendor, Memry Corporation in Bethel, Connecticut, to produce steering wire subassemblies currently manufactured in-house at Boston Scientific Corporation.

P970004/S019

12/14/01

Implantable Neurostimulator (INS – formerly IPG) Model 3023

Medtronic, Inc.

Minneapolis, MN

55421

Change in the sterile packaging operation from a Class 10,000 controlled environment area (CEA) to a Class 100,000 CEA.

P980035/S017

12/28/01

Medtronic Sigma and Medtronic 350 Series Pulse Generators

Medtronic, Inc.

Minneapolis, MN

55432

Change in the cleaning process to add an Atmospheric Glow Discharge Process in place of the heptane wipe.

P990074/S010

12/12/01

Saline-Filled Breast Implants

McGhan Medical Corporation

Santa Barbara, CA

93111

Elimination of destructive Finished Product Release Testing (FPRT) based on an assessment of the critical control points of the manufacturing process by the Hazard Analysis Critical Control Point (HACCP) method.

P000052/S001

12/18/01

GALILEO™ Intravascular Radiotherapy System

Guidant Corporation

Houston, TX

77054

Modification of a manufacturing process, incorporating additional environmental controls, for the GDT-P32-2 (27 mm) source wire component of the GALILEO™ Intravascular Radiotherapy System.