P970027

2/5/04

Abbott AxSym Antibody to HCV

Abbott Laboratories

Abbott Park, IL

60064

Approval for the Abbott AxSYM Antibody to HCV.  The device is indicated for the qualitative detection of anti-HCV recombinant proteins in human serum or plasma (potassium EDTA, sodium EDTA, sodium heparin, lithium heparin, sodium citrate, and potassium oxalate).

P980007

2/5/04

AxSYM® Free PSA

Abbott Laboratories

Abbott Park, IL

60064

Approval for the AxSYM® Free PSA Assay.  The device is a microparticle enzyme immunoassay (MEIA) for the quantitative measurement of free prostate specific antigen (PSA) in human serum.  The AxSYM Free PSA assay is intended to be used in PSA values between 4 and 10 ng/ml and non-suspicious DRE to determine the % Free PSA Value.  The AxSYM% Free PSA value can be used as an aid in discriminating between prostate cancer and benign disease.

P030006

2/19/04

Prolieve™ Thermodilatation System

Celsion Corporation

Columbia, MD

21046

Approval the Prolieve™ Thermodilatation System, which is a transurethral microwave therapy device that provides a non-surgical, minimally invasive procedure for the treatment of symptomatic BHP in men with a prostate size of 20 to 80 grams, a prostatic urethra length of 1.2 to 5.5 cm and in whom drug therapy (e.g., Proscar®) in typically indicated.

P030019

2/4/04

ORTHOVISC® High Molecular Weight Hyaluronan

Anika Therapeutics, Inc.

Woburn, MA

01801

Approval for the ORTHOVISC® High Molecular Weight Hyaluronan.  The device is indicated fo the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetaminophen).

P030044

2/12/04

DakoCytomation EGFR pharmDx™

DakoCytomation California, Inc.

Carpinteria, CA

93013

Approval for the DakoCytomation EGFR pharmDx.  The device is indicated for:  the EGFR pharmDX assay is a qualitative immunohistochemical (IHC) kit system to identify epidermal growth factor receptor (EGFR) expression in normal and neoplastic tissues routinely-fixed for histological evaluation.  EGFR pharmDx specifically detects the EGFR (HER1) protein in EGFR-expressing cells.  EGFR pharmDx is indicated as an aid in identifying colorectal cancer patients eligible for treatment with ERBITUX (cetuximab).

N18033/S039

2/4/04

Real-Time

ACUVUE® COLOURS™ Brand (etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker

VISTAKON, Division of Johnson and Johnson Vision Care, Inc.

Jacksonville, FL

32256

Approval for an alternative binding polymer to the ACUVUE 2 COLOURS Brand (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker.

P780012/S009

2/2/04

180-Day

Abbott Axsym HAVAB® 2.0

Abbott Laboratories

Abbott Park, IL

60064

Approval for the Abbott Axsym HAVAB® 2.0.  The device, as modified, will be marketed under the trade name Axsym HAVAB® 2.0 and is indicated for the qualitative detection of total antibody to hepatitis A virus (anti-HAV) in human serum or plasma.  A test for anti-HAV is indicated as an aid in the diagnosis of previous or ongoing hepatitis A viral infection or in the identification of HAV-susceptible individuals for vaccination.

P790019/S011

2/2/04

180-Day

Abbott AxSYM HAVAB-M® 2.0

Abbott Laboratories

Abbott Park, IL

60064

Approval for the Abbott AxSYM HAVAB-M® 2.0.  The device, as modified, will be marketed under the trade name AxSYM HAVAB-M® 2.0 and is indicated for the qualitative detection if IgM antibody to hepatitis A virus (IgM anti-HAV) in human serum or plasma.  A test for IgM anti-HAV is indicated as an aid in the diagnosis of acute or recent hepatitis A viral infection.

P820060/S013

2/2/04

180-Day

Abbott Architect AFP

Abbott Laboratories

Abbott Park, IL

60064

Approval for the addition of the AFP assay on the Architect immunoassay instrument.  The device, as modified, will be marketed under the trade name Architect AFP assay and is indicated for the quantitative determination of alpha-fetoprotein (AFP) in : 1) Human serum or plasma to aid in the management of patients with nonseminomatosus testicular cancer.  2) Human serum, plasma, and amniotic fluid at 15 to 21 weeks gestation to aid in the detection of fetal open neural tube defects (NTD).

P820060/S016

2/2/04

180-Day

Abbott Architect AFP for the Architect i2000_sr analyzer

Abbott Laboratories

Abbott Park, IL

60064

Approval for the use of the Abbott Architect AFP assay on the Architect i2000_sr analyzer.  The device, as modified, will be marketed under the trade name Abbott Architect AFP assay for the Architect i2000 analyzer and is indicated for the following: 1) Human serum or plasma to aid in the management of patients with nonseminomatosus testicular cancer.  2) Human serum, plasma, and amniotic fluid at 15 to 21 weeks gestation to aid in the detection of open neural tube defects (NTD).  Test results when used in conjunction with ultrasonography or amniography are a safe and effective aid in the detection of fetal open NTD.

P820060/S019

2/2/04

Real-Time

Abbott AxSYM AFP

Abbott Laboratories

Abbott Park, IL

60064

Approval for a change in protocol for the automated dilution protocol in Abbott AxSYM software version 3.60 and version 4.01.

P830055/S085

2/25/04

180-Day

LCS Total Knee System

Depuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for a manufacturing facility for the trochlear components of the patellofemoral replacement system, in Vandalia, Ohio.

P890019/S009

2/20/04

Special

DiaSorin ETI-AB-HAVK PLUS Assay

DiaSorin, Inc.

Stillwater, MN

55082

Approval for the following changes to the package insert:  The supplement contains a revision in the assay package insert that states “All lots of incubation buffer are interchangeable between ETI-EBK PLUS, ETI-AB-EBK PLUS, ETI-AB-HAVK PLUS.”

P910007/S005

2/2/04

180-Day

Abbott AxSYM Total PSA

Abbott Laboratories

Abbott Park, IL

60064

Approval for the Abbott AxSYM Total PSA assay.  The AxSY Total PSA assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of total PSA (both free PSA and PSA complexed to alpha-1 antichymotrypsin) in human serum:  1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men 50 years or older.  Prostate biopsy is required for diagnosis of cancer.  2) as an adjunctive test to aid in the management of prostate cancer patients.

P910007/S007

2/2/04

180-Day

Architect Total PSA assay

Abbott Laboratories

Abbott Park, IL

60064

Approval for the Abbott Architect Total PSA assay.  The Architect Total PSA assay is indicated:  1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men 50 years or older.  Prostate biopsy is required for diagnosis of cancer.  2) as an adjunctive test to aid in the management of prostate cancer patients.

P910007/S009

2/2/04

180-Day

Abbott IMx Total PSA assay

Abbott Laboratories

Abbott Park, IL

60064

Approval for the Abbott IMx Total PSA assay.  The device, as modified, will be marketed under the trade name Abbott IMx Total PSA assay and is indicated as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men aged 50 years or older.  Prostatic biopsy is required for the diagnosis of cancer.

P910077/S041

2/6/04

180-Day

VENTAK AV, PRIZM, VITALITY, VITALITY AVT Implantable Cardioverter Defibrillators

Guidant Corporation

St. Paul, MN

55112

Approval for changes to the Indications for Use and Clinical Study section labeling.  The devices are indicated for:  For ICDs (VENTAK PRx, MINI, VITALITY, VENTAK AV and PRIZM): Guidant ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.  For VITALITY AVT:

Guidant VITALITY AVT is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.  This device is also intended to provide atrial antitachycardia pacing and atrial defibrillation treatment in patients who have or are at risk of developing atrial tachyarrhythmias.

For CRT-Ds (CONTAK CD and RENEWAL):

Guidant Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.  Guidant CRT-Ds are also indicated for reduction of symptoms of moderate to severe heart failure (NYHA III/IV) in patients who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF≤ 35%) and QRS duration ≥ 120 ms.

P930029/S021

2/5/04

Real-Time

Medtronic RF Enhancr® II Family of Ablation Catheters

Medtronic EP Systems

Minneapolis, MN

55432

Approval for a line extension to the commercially available RF Enhancr® catheter line with the changes limited to a new handle design and associated packaging changes.  The device, as modified, will be marketed under the trade name Medtronic RF Enhancr® II family of Ablation Catheters and is indicated for use with the Medtronic RF Power generator to deliver RF energy for intracardiac ablation of accessory atrioventricular (AV) conduction pathways associated with tachycardia for the treatment of AV nodal re-entrant tachycardia and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.

P930039/S017

2/9/04

Real-Time

Medtronic CapSureFix Novus Model 4076 Lead

Medtronic, Inc.

Minneapolis, MN

55432

Approval for modifications to the Model 4076 lead.

P950029/S019

2/13/04

Real-Time

Symphony/ELA Rhapsody ROM Mask T3 (Version GXD T3)

ELA Medical, Inc.

Plymouth, MN

55441

Approval for the firmware modifications (Version GXD T3) of the Symphony and ELA Rhapsody pacemakers.

P950039/S011

2/9/04

180-Day

Thinprep 2000 System

Cytyc Corporation

Boxborough, MA

01719

Approval for an additional manufacturing site for the filter manufacturing process.  The site is located at Cytyc New Hampshire, Londonderry, New Hampshire.

P960040/S036

2/6/04

180-Day

VENTAK PRx and MINI Implantable Cardioverter Defibrillators

Guidant Corporation

St. Paul, MN

55112

Approval for changes to the Indications for Use and Clinical Study section labeling.  The devices are indicated for:  For ICDs (VENTAK PRx, MINI, VITALITY, VENTAK AV and PRIZM): Guidant ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.  For VITALITY AVT:

Guidant VITALITY AVT is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.  This device is also intended to provide atrial antitachycardia pacing and atrial defibrillation treatment in patients who have or are at risk of developing atrial tachyarrhythmias.

For CRT-Ds (CONTAK CD and RENEWAL):

Guidant Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.  Guidant CRT-Ds are also indicated for reduction of symptoms of moderate to severe heart failure (NYHA III/IV) in patients who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF≤ 35%) and QRS duration ≥ 120 ms.

P960043/S048

2/11/04

180-Day

Perclose® ProGlide™ 6 French Suture Mediated Closer (SMC) System

Abbott Vascular Devices

Redwood City, CA

94063

Approval for a name change, from Perclose® AT Mono-Glide 6 French Suture Mediated Closer (SMC) System to Perclose® ProGlide™ 6 French Suture Mediated Closer (SMC) Systems.  The device, as modified, will be marketed under the trade name Perclose® ProGlide™ 6 French Suture Mediated Closer (SMC) Systems and is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using 5 to 8 Fr. sheaths.  The Perclose® ProGlide™ 6 French Suture Mediated Closer (SMC) Systems reduce the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic or interventional catheterization procedures without complicating clinical conditions.

P960058/S033

2/18/04

Real-Time

HiResolution™ Bionic Ear System

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for a new Auria (behind-the-ear) accessory, called the Auria™ T-Coil.  The accessory provides Auria users an optional interface for telephones and induction loop-based assistive listening system.

P970043/S016

2/9/04

Real-Time

LADARVision® 4000 Excimer Laser System

Alcon Laboratories, Inc.

Orlando, FL

32826

Approval for a new laser assembly system to replace the existing assembly in the approved LADARVision® 4000 Excimer Laser System.

P980003/S009

2/5/04

Real-Time

Chilli® Cooled Ablation Catheters

Boston Scientific Corporation

San Jose, CA

95134

Approval for the use of the Chilli catheters with the EPT-1000 XP RF generator using the same maximum output power as that used with the Model 8004 and EPT-1000 TC generators.

P980006/S005

2/11/04

180-Day

PureVision™ (balafilcon A) Visibility Tinted Contact Lens

Bausch & Lomb

Rochester, NY

14609

Approval to modify the post-approval study for the device.

P980007/S002

2/5/04

180-Day

Abbott Architect Free PSA

Abbott Laboratories

Abbott Park, IL

60064

Approval for the Architect Free PSA assay.

P980007/S003

2/5/04

180-Day

Abbott IMx® Free PSA

Abbott Laboratories

Abbott Park, IL

60064

Approval for modification of the Abbott Architect Free PSA reagents to be used with the IMx® Free PSA and is indicated for:  The IMx® Free PSA assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of free prostate specific antigen (PSA) in human serum.  The IMx® Free PSA Assay is intended to be used in conjunction with the IMx® Total PSA assay in men aged 50 years or older with total PSA values between 4 and 10 ng/mL and non-suspicious DRE to determine the % free PSA value.  The IMx % free PSA value can be used as an aid in discriminating between prostate cancer and benign disease.

P980035/S032

2/20/04

180-Day

EnPulse™ Implantable Pulse Generator Models E2DR01, E2DR03, E2DR06, E2DR21, E2DR31, E2DR33, E2D01, E2D03, E2VDD01, E2SR01, E2SR03, E2SR06 and Model 9991 Application Software

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the EnPulse™ Implantable Pulse Generator Models E2DR01, E2DR03, E2DR06, E2DR21, E2DR31, E2DR33, E2D01, E2D03, E2VDD01, E2SR01, E2SR03, E2SR06 with Atrial Capture Management and Model 9991 Application Software.  The device, as modified, will be marketed under the trade name EnPulse™ IPG and is indicated as follows:  EnPulse™ pacemakers are indicated for use in patients who are experiencing accepted conditions warranting chronic cardiac pacing which include: 

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

2) Symptomatic bilateral bundle branch block 

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

4) Bradycardia-tachycardia syndrome 

5) Vasovagal syndromes or hypersensititve carotid sinus syndromes.  EnPulse™ pacemakers are also indicated for use in patients who may benefit from rate responsive pacing to support cardiac output during varying levels of activity.  Using rate response modes may restore heart rate variability by improving cardiac output.  These devices are also indicated for use in patients who may benefit from maintenance of AV synchrony through the use of dual chamber modes and atrial tracking modes.  Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony.  Dual chamber modes are indicated for use in patients who have experienced one or both of the following conditions. 

1) Various degrees of AV block 

2) VVI intolerance (for example, pacemaker syndrome) in presence of persistent sinus rhythm.  The device is also indicated for VDD pacing in patients who have adequate rates and on or both of the following conditions.  1) A requirement 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 had existed or is anticipated.  2) A requirement for intermittent ventricular pacing despite a normal sinus rhythm and normal AV conduction.

P980035/S033

2/17/04

Real-Time

Medtronic Sigma Models SS106, SSR306, SC203, SDR203, SD303, SDR303, DR353 and SVDD303

Medtronic, Inc.

Minneapolis, MN

55432

Approval for minor manufacturing modifications and improvements.

P990026/S021

2/25/04

180-Day

GlucoWatch G2 Biographer

Cygnus, Inc.

Redwood City, CA

94063

Approval for an expansion of the labeling to include a description of pre-treatment products and a method to minimize the affects of skin irritation without affecting the accuracy of G2 Biographer glucose measurements.

P990041/S004

2/20/04

Special

DiaSorin ETI-AB-EBK PLUS Assay

DiaSorin, Inc.

Stillwater, MN

55082

Approval for the following changes to the package insert:  The supplement contains a revision in the assay package insert that states “All lots of incubation buffer are interchangeable between ETI-EBK PLUS, ETI-AB-EBK PLUS, ETI-AB-HAVK PLUS.”

P990043/S005

2/12/04

Special

DiaSorin ETI-EBK PLUS Assay

DiaSorin, Inc.

Stillwater, MN

55082

Approval for the following changes to the package insert:  The supplement contains a revision in the assay package insert that states “All lots of incubation buffer are interchangeable between ETI-EBK PLUS, ETI-AB-EBK PLUS, ETI-AB-HAVK PLUS.”

P990054/S005

2/9/04

Real-Time

Chilli® and Chilli® RPM Cooled Ablation Catheters

Boston Scientific Corporation

San Jose, CA

95134

Approval for the use of the Chilli and Chilli RPM catheters with the EPT-1000 XP RF generator using the same maximum output power as that used with the Model 8004 and EPT-1000 TC generators.

P990066/S016

2/19/04

180-Day

Senographe 2100D Full Field Digital Mammography System

GE Medical Systems

Milwakee, WI

53188

Approval for changes in ergonomics, the image acquisition chain, image presentation on the AWS, and connectivity.  In addition the application requested additional image quality claims and QC manual changes for QC test technique factors and procedures under MQSA.  The device, as modified, will be marketed under the trade name Senographe 2100D Full Field Digital Mammography System.

P990071/S004

2/24/04

Real-Time

Stockert 70 Remote Control accessory and Connection Cable

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for the addition of a Stockert Remote Control and Connection Cable.  The device, as modified, will be marketed under the trade name Stockert Remote Control and Connection Cable and is indicated for use in conjunction with the Stockert 70 Radiofrequency Generator to be used in conjunction with a compatible catheter for cardiac ablation procedures.

P000018/S035

2/17/04

180-Day

Novoste™

Beta-Cath™ System

Novoste Corporation

Norcross, GA

30093

Approval for modifications to the Alpha-series Transfer Devices (Alpha IV, Rev. 2, Alpha V, and Alpha VI), and modifications to the labeling for the Beta-Cath™ 5F and Beta-Cath™ 3.5F Systems.

P000040/S004

2/24/04

180-Day

HTA® System

Boston Scientific Corporation

Natick, MA

01760

Approval for updated labeling that reflects the 2 and 3 year patient follow-up data.  The device, as modified, will be marketed under the trade name HTZ® System and is indicated for ablation of the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

P010012/S017

2/6/04

180-Day

CONTAK CD and RENEWAL Cardiac Resynchronization Therapy Defibrillators

Guidant Corporation

St. Paul, MN

55112

Approval for changes to the Indications for Use and Clinical Study section labeling.  The devices are indicated for:  For ICDs (VENTAK PRx, MINI, VITALITY, VENTAK AV and PRIZM): Guidant ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.  For VITALITY AVT:

Guidant VITALITY AVT is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.  This device is also intended to provide atrial antitachycardia pacing and atrial defibrillation treatment in patients who have or are at risk of developing atrial tachyarrhythmias.

For CRT-Ds (CONTAK CD and RENEWAL):

Guidant Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.  Guidant CRT-Ds are also indicated for reduction of symptoms of moderate to severe heart failure (NYHA III/IV) in patients who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF≤ 35%) and QRS duration ≥ 120 ms.

P010012/S022

2/12/04

Special

EASYTRAK IS-1 Lead, Models 4535, 4536, 4537, 4538; EASYTRAK 1 Lead Models 4510, 4511, 4512, 4513

Guidant Corporation

St. Paul, MN

55112

Approval to modify lead manuals.

P010013/S006

2/5/04

180-Day

NovaSure Impedence Controlled Endometrial Ablation System

Novacept, Inc.

Palo Alto, CA

94303

Approval for a manufacturing site located at Novacept, Heredia, Costa Rica.

P010031/S008

2/6/04

180-Day

InSync® II Protect Model 7295 with Model 9992 Application Software

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic® InSync® II Protect Model 7295 with Model 9992 Application Software.  The device, as modified, will be marketed under the trade name Medtronic® InSync® II Protect Model 7295 with Model 9992 Application Software and is indicated as follows: 

The InSync ® II Protect provides ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.  The system is also indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction < 35% and a QRS duration > 130 ms. The InSync II Protect device only allows arrhythmias in the VF zone to receive treatment.  Arrhythmias in the Monitor Only zone will not be treated by the device.

P010065/S002

2/5/04

180-Day

NeedleZap

E Med Future, Inc.

Columbus, OH

43230

Approval for a manufacturing site located at Frantz Medical Development, Ltd., Mentor, Ohio.

P020004/S005

2/25/04

180-Day

Gore EXCLUDER™ Bifurcated Endoprosthesis

W.L. Gore & Associates, Inc.

Flagstaff, AZ

860001

Approval for a modified version of the Gore EXCLUDER™ Bifurcated Endoprosthesis.

P020018/S001

2/2/04

180-Day

Zenith™ AAA Endovascular Graft and H&L-B One-Shot™ Introduction System

Cook, Inc.

Bloomington, IN

47402

Approval for the long-term study of the device.

P020018/S002

2/12/04

180-Day

Zenith™ AAA Endovascular Graft and H&L-B One-Shot™ Introduction System

Cook, Inc.

Bloomington, IN

47402

Approval to increase the diameter of the suprarenal attachment barb of the Zenith® AAA Endovascular Graft.

P020023/S001

2/4/04

Real-Time

Restylane™ Injectable Gel

Q-Med Scandinavia, Inc.

Princeton, NJ

08540

Approval for increasing the expiration dating from Restylane form 12 months to 24 months.

P020025/S001

2/23/04

180-Day

Blazer XP RPM

Boston Scientific Corporation

San Jose, CA

95134

Approval for the Blazer XP RPM Catheter which combines the features of the Blazer II XP with the Real Time Position Management (RPM) tracking system technology approved for the Chilli RPM Catheter.

P830060/S053

2/10/04

Ventak

Guidant Corporation

St. Paul, MN

55112

Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release.

P910073/S044

2/10/04

Endotak/Endurance/Reliance

Guidant Corporation

St. Paul, MN

55112

Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release.

P910077/S044

2/10/04

Ventak PRx/     Mini III/Mini IV

Guidant Corporation

St. Paul, MN

55112

Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release.

P940008/S018

2/10/04

RES-Q

Guidant Corporation

St. Paul, MN

55112

Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release.

P940031/S030

2/10/04

Meridian/Discovery

Guidant Corporation

St. Paul, MN

55112

Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release.

P940034/S015

2/10/04

Amplified Mycobacterium Tuberculosis Direct Test

Gen-Probe, Inc.

San Diego, CA

92121

Change to QC specification for the release of the Amplification Reagent.

P950001/S010

2/10/04

Selute

Guidant Corporation

St. Paul, MN

55112

Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release.

P960004/S024

2/10/04

Fineline/Thinline

Guidant Corporation

St. Paul, MN

55112

Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release.

P960006/S009

2/10/04

Sweet Tip Rx/ Sweet Picotip Rx/ Flextend

Guidant Corporation

St. Paul, MN

55112

Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release.

P960040/S040

2/10/04

Ventak AV/ Prizm/Prizm 2/ Vitality

Guidant Corporation

St. Paul, MN

55112

Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release.

D970003/S027

2/10/04

Pulsar Max/ Discovery II/ Insignia

Guidant Corporation

St. Paul, MN

55112

Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release.

P980003/S012

2/9/04

Chilli II Cooled Ablation Catheter

Boston Scientific Corporation

San Jose, CA

95134

Four manufacturing changes:  1) change to cooling lumen extrusion; 

2) change to the cleaning process; 

3) change in the wrap; and  4) change in the distal ring electrode grooves.

P990046/S010

2/27/04

ATS Open Pivot Bileaflet Heart Valve

ATS Medical

Minneapolis, MN

55447

Change in the grinding operation used during manufacturing of orifices.

P000025/S013

2/25/04

MED-EL COMBI 40+ Cochlear Implant System

MED-EL Corporation

Durham, NC

27713

Addition of an alternative supplier for the electrode wire used in the MED-EL Combi 40+ Cochlear Implant.

P000033/S001

2/13/04

IntraCoil® Peripheral

stent

ev3

Plymouth, MN

55442

Change in the manufacturing process to propose an alternate wire polishing vendor for the nitinol wire polishing process.

P010012/S021

2/10/04

Contak CD/ CD2/Renewal/ Easytrak

Guidant Corporation

St. Paul, MN

55112

Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release.

P010033/S007

2/10/04

QuantiFERON®-TB

Cellestis, Inc.

Valencia, CA

91355

Change to the manufacturing process of the QuantiFERON®-TB to an alternative substrate reagent to increase the shelf life of the kit to 3 years.

P020023/S002

2/13/04

Restylane™ Injectable Gel

Q-Med AB

Upsalla, Sweden

S-752 28

Two manufacturing changes involving the Restylane production process.