FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH

PMA Final Decisions Rendered for March 2003

P010065

3/14/03

NeedleZap™

E Med Future, Inc.

Columbus, OH

43230

Approval for the NeedleZap.  The device is a portable needle destruction device that is indicated for use by health care professionals to destroy previously used aluminum and stainless steel needles (gauges

16 - 30, ¾ - 2 inches in length) attached to syringes.  The NeedleZap product is intended for use in health care facilities and treatment settings.

P020022

3/28/03

Bayer Versant™ HCV RNA 3.0 Assay (bDNA)

Bayer Diagnostics

Berkeley, CA

94702

Approval for the Bayer Versant HCV RNA 3.0 Assay (bDNA).  The device is indicated for:  The VERSANT HCV RNA 3.0 Assay (bDNA) is a signal amplification nucleic acid probe assay for the quantitation of human hepatitis C viral RNA (HCV RNA) in the serum or plasma (EDTA and ACD) of HCV-infected individuals using the Bayer System 340 bDNA Analyzer.  Specimens containing HCV genotypes 1-6 have been validated for quantitation in the assay.  The VERSANT HCV RNA 3.0 Assay is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy.  The assay measures HCV RNA levels at baseline and during treatment and are useful in predicting non-response to HCV therapy, and are predictive of non-sustained virological response.  The results from the VERSANT HCV RNA 3.0 Assay (bDNA) must be interpreted within the context of all relevant clinical and laboratory findings.  Assay performance characteristics have been established only for individuals treated with interferon alfa-2b plus ribavirin.  No information is available on the assay predictive values when other therapies are used.

P020041

3/28/03

FemCap™ Barrier Contraceptive

FemCap, Inc.

Del Mar, CA

92014

Approval for the FemCap™ Barrier Contraceptive.  The FemCap™ is indicated for use by women of childbearing age who desire to prevent or postpone pregnancy.

P790017/S079

3/4/03

Real-Time

NC Stormer Over-The-Wire Balloon Dilatation Catheter and NC Stormer Zipper MX Balloon Dilatation Catheter

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Approval to make modifications to the Stormer Balloon Dilatation Catheter with Zipper Delivery.  The devices, as modified, will be marketed under the trade names NC Stormer Over-The-Wire Balloon Dilatation Catheter and NC Stormer Zipper MX Balloon Dilatation Catheter and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.  The NC Stormer balloon dilatation catheter (balloon models 2.5 mm – 4.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents.  NOTE:  bench testing was conducted with the NC Stormer balloon dilatation catheter and marketed balloon expandable stents.  Consideration would be taken when the device is used with different manufacturers’ stents due to differences in stent design.

P800022/S050

3/11/03

Panel

CosmoDerm™ 1 Human-Based Collagen, CosmoDerm™ 2 Human-Based Collagen and CosmoPlast™ Human-Based Collagen

Inamed Corporation

Santa Barbara, CA

93111

Approval for CosmoDerm™ 1 Human-Based Collagen, CosmoDerm™ 2 Human-Based Collagen and CosmoPlast™ Human-Based Collagen.  The indications for use are as follows: CosmoDerm™ 1 Human-Based Collagen and CosmoDerm™ 2 Human-Based Collagen are injected into the superficial papillary dermis for correction of soft tissue contour deficiencies, such as wrinkles and acne scars, and CosmoPlast™ Human-Based Collagen is injected into the mid to deep dermis for correction of soft tissue contour deficiencies, such as wrinkles and acne scars.

P820060/S017

3/5/03

Special

AFP Control Pack

Abbott Laboratories

Abbott Park, IL

60064

Approval for initiating heat stress reference testing for the Plasma Diagnostic Base (PDB; control diluent) used in the preparation of the controls for the AFP assays.

P830037/S048

3/6/03

Real-Time

FreshLook® Dimensions™ (phemfilcon A) Soft (hydrophilic) Contact Lenses for Extended Wear up to 7 days/6 nights (Spherical and Toric with or without UV absorber; Cast-molded)

CIBA Vision Corporation

Duluth, CA

30097

Approval for the FreshLook® Dimensions™ (phemfilcon A) Soft (hydrophilic) Contact Lens indicated for extended wear up to 6 nights/7 days.  This device will be an optimized combination of two of the previously approved processes; namely, current FreshLook® ColorBlends (multiple print) Printing Process (P830037/S045) and the FreshLook® Handling Tint Monomer Tinting Process (830037/S039).  This additional process of printing onto a tinted lens for the FreshLook® (phemfilcon A) Soft (hydrophilic) Contact Lens family offers the patient a contact lens option with a better contrast in the printed portion of the lens.  The device, as modified, will be marketed under the FreshLook® trade name with the following indication:  FreshLook® Dimensions™ (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity.  The lens acts to enhance or alter the apparent color of the eye.  FreshLook® Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.0 diopters.  The lens acts to enhance or alter the apparent color of the eye.  The lenses may be prescribed for extended wear in not-aphakic persons from 1-7 days between removal for cleaning and disinfection or disposal, as recommended by the eye care practitioner.  The eye care practitioner may prescribe the lens in either a single use disposable program or in a frequent replacement program with cleaning, disinfection, and scheduled replacement.  When prescribed in a frequent replacement program, the lens may be disinfected using a chemical disinfection system.  FreshLook® Soft Contact Lenses with UV absorbing monomer help protect against transmission of harmful UV radiation to the cornea and into the eye.

P830045/S085

3/20/03

Real-Time

Identity ADx Models XL DR 5386 and DR 5380 Pulse Generators and programmer software Model 3307 v4.2a

St. Jude Medical, Inc.

Sylmar, CA

91342

Approval for the Identity ADx Models XL DR 5386 and DR 5380 Pulse Generators and programmer software Model 3307 v4.2a.  These devices are indicated as follows:  Implantation of Identity ADx Models 5386 and 5380 pulse generators is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncope, fatigue, disorientation, or any combination of those symptoms.  Dual-Chamber Pacing is indicated for those patients exhibiting: sick sinus syndrome, chronic symptomatic second- and third-degree AV block, recurrent Adams-Stokes syndrome, and symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out.  Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems.  Ventricular Pacing is indicated for patients with significant bradycardia and: normal sinus rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation and severe physical disability.  AF Suppression is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.

P850048/S019

3/3/03

Real-Time

Access Hybritech® PSA on the UniCel™ DxI 800 Access® Immunoassay System

Beckman Coulter, Inc.

Chaska, MN

55318

Approval to add the Access Hybritech PSA Assay to the UniCel™ DxI 800 Access Immunoassay System.

P860026/S008

3/3/03

180-Day

Diaphragmatic Pacemaker Phrenic Nerve Stimulator

Avery Laboratories, Inc.

Commack, NY

11725

Approval for selecting a final value of C22 and C50 capacitors during production testing based on parameters measured with calibrated test equipment to result in peak operating performance of the transmitter.

P880086/S093

3/20/03

Real-Time

Identity ADx Models XL DR 5386 and DR 5380 Pulse Generators and programmer software Model 3307 v4.2a

St. Jude Medical, Inc.

Sylmar, CA

91342

Approval for the Identity ADx Models XL DR 5386 and DR 5380 Pulse Generators and programmer software Model 3307 v4.2a.  These devices are indicated as follows:  Implantation of Identity ADx Models 5386 and 5380 pulse generators is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncope, fatigue, disorientation, or any combination of those symptoms.  Dual-Chamber Pacing is indicated for those patients exhibiting: sick sinus syndrome, chronic symptomatic second- and third-degree AV block, recurrent Adams-Stokes syndrome, and symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out.  Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems.  Ventricular Pacing is indicated for patients with significant bradycardia and: normal sinus rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation and severe physical disability.  AF Suppression is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.

P890064/S009

3/31/03

Panel

Digene Hybrid Capture® 2 (HC2) High-Risk HPV DNA Test

Digene Corporation

Gaithersburg, MD

20878

Approval for the Digene Hybrid Capture® 2 (HC2) High-Risk HPV DNA Test.  The device is indicated for:  1) To screen patients with ASCUS (atypical squamous cells of undetermined significance) Pap smear results to determine the need for referral to colposcopy.  The results of this test are not intended to prevent women from proceeding to colposcopy.  2) In women 30 years and older the HC2 High-Risk HPV DNA Test can be used with Pap to adjunctively screen to assess the presence or absence of high-risk HPV types.  This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

P910018/S007

3/6/03

180-Day

Liposorber® LA-15 System

Kaneka Pharma America Medical Corporation

New York, NY

10022

Approval for the transfer of the assembly and soldering of printed circuit boards used in conjunction with the final assembly of the MA-01 Apheresis Machine to Yokogawa Ibiden Components Corporaiton, Oume-City, Tokyo 198 JAPAN.

P910023/S066

3/20/03

Real-Time

Identity ADx Models XL DR 5386 and DR 5380 Pulse Generators and programmer software Model 3307 v4.2a

St. Jude Medical, Inc.

Sylmar, CA

91342

Approval for the Identity ADx Models XL DR 5386 and DR 5380 Pulse Generators and programmer software Model 3307 v4.2a.  These devices are indicated as follows:  Implantation of Identity ADx Models 5386 and 5380 pulse generators is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncope, fatigue, disorientation, or any combination of those symptoms.  Dual-Chamber Pacing is indicated for those patients exhibiting: sick sinus syndrome, chronic symptomatic second- and third-degree AV block, recurrent Adams-Stokes syndrome, and symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out.  Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems.  Ventricular Pacing is indicated for patients with significant bradycardia and: normal sinus rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation and severe physical disability.  AF Suppression is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.

P910077/S039

3/21/03

180-Day

Ventak PRx and MINI ICDs

Guidant Corporation

St. Paul, MN

55112

Approval for changes to the patient handbooks.

P920014/S020

3/21/03

Special

Thoratec® HeartMate® Stroke Volume Limiter

Thoratec Corporation

Pleasanton, CA

94588

Approval for specific additional safety instructions to the labeling for the Stroke Volume Limiter.

P930021/S006

3/28/03

180-Day

Emdogain™ Gel

Biora, Inc.

Chicago, IL

60610

Approval for extension of the expiration date on Emdogain® Gel from 18 months to 24 months.

P930029/S020

3/3/03

Real-Time

Medtronic Atakr II Model 4802 (60W) Software Version 1.36

Medtronic EP Systems

Minneapolis, MN

55432

Approval for a software upgrade (version 1.36) for the Medtronic Atakr II Model 4802 (60SW) radio frequency generator.

P940015/S009

3/14/03

Special

Synvisc® (hylan

G-F 20)

Genzyme Biosurgery

Cambridge, MA

02139

Approval for the addition of the following precaution statement to the Synvisc® Physician Package Insert:  “Twist the gray tip cap before pulling it off, as this will minimize product leakage”.

P940031/S027

3/21/03

180-Day

Vigor DR/SR and Discovery Meridian AR

Guidant Corporation

St. Paul, MN

55112

Approval for changes to the patient handbooks.

P950018/S009

3/20/03

Real-Time

Perfluoron™

Alcon Laboratories

Fort Worth, TX

76134

Approval for a new stability protocol that will extend the expiration dating for Perfluoron from 2 years to up to 4 years for the currently approved product configuration, with stability testing data reported via annual reports in the future.

P950020/S006

3/11/03

180-Day

Cutting Balloon™

Boston Scientific – Interventional Technologies

San Diego, CA

92123

Approval for:  1) use of the Bioslide™ coating on all Cutting Balloon™ models, and  2) use of a revised Y-site on Over-the-Wire (OTW) Cutting Balloon™ models.  The device, as modified, will be marketed under the trade name Cutting Balloon™ Monorail/OTW 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 º), smooth angiographic contour; and absence of angiographically-visible thrombus and/or calcification.

P950022/S016

3/25/03

Real-Time

Riata Defibrillation Lead System Model 1572 and 1582

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for single defibrillation coil lead models 1572 and 1582.

P950039/S010

3/27/03

Special

ThinPep® 2000 System and ThinPrep® 3000 Processor: PreservCyt Solution, Alternative Transport Medium for Roche Diagnostics COBAS AMPLICOR CT/NG Test.

Cytyc Corporation

Boxborough, MA

01719

Approval for labeling changes for the PreservCyt Solution as an Alternative Transport Medium for Roche Diagnostics COBAS AMPLICOR CT/NG Test.

P960016/S009

3/28/03

Real-Time

Livewire TC™ Cardiac Ablation System

St. Jude Medical

Minnetonka, MN

55345

Approval for revised indications for use for these models of Livewire TC™ ablation catheters: 5mm Livewire TC™ Steerable Electrophysiology Catheters XLS With Universal Sensor (Models 402205-402208); 5mm Livewire TC™ Steerable Electrophysiology Catheters XLS With Thermistor (Models 402209-402212); 5mm Livewire TC™ Steerable Electrophysiology Catheters XLS with Thermocouple (Models 402213-402216); 4mm Livewire TC™ Steerable Electrophysiology Cathether With Thermistor (Models 402229-402232); and 4mm Livewire TC™ Steerable Electrophysiology Catheter XLS with Thermistor (Models 402233-402236).  The catheters are indicated for cardiac electrophysiological mapping and for use with a compatible RF generator for creating endocardial lesions during cardiac ablation procedures to treat arrhythmias.

P960040/S028

3/27/03

Panel

VENTAK PRIZM® AVT™ AICD System Model 1900; Programmer Software Application Model 2849 Version 2.4; PERIMETER™ CS Coronary Sinus Defibrillation Lead Models 0202, 0203, and 0204; Stylet Accessory Kits Models 6321, 6322, 6323, 6324, 6325, 6326, 6327, 6328, and 6329; and PARTNER™ Rhythm Assistant Model 2930

Guidant Corporation

St. Paul, MN

55112

Approval for the VANTAK PRIZM AVT® AICD System.  The device is indicated for use in the following: Patients who are ICD indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias.  Patient populations who are indicated for a Guidant ICD include:  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).

P960040/S029

3/26/03

180-Day

Vitality™ AVT™ and the Programmer Software Application Model 2812

Guidant Corporation

St. Paul, MN

55112

Approval for the addition of atrial arrhythmia therapies to the Vitality™ AICD System.  The device, as modified, will be marketed under the trade name Vitality™ AVT™ and Programmer Software Application Model 2812, and is indicated for use in the following:  Patients who are ICD indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias.  Patient populations who are indicated for a Guidant ICD include:  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).

P960040/S030

3/21/03

180-Day

Ventak AV and Ventak Prizm DR/VR AICDs

Guidant Corporation

St. Paul, MN

55112

Approval for changes to the patient handbooks.

D970003/S019

3/21/03

180-Day

PULSAR MAX

Guidant Corporation

St. Paul, MN

55112

Approval for changes to the patient handbooks.

P970021/S007

3/27/03

180-Day

Gynecare Thermachoice Uterine Balloon Therapy System

Gynecare, a division of Ethicon, Inc.

Somerville, NJ

08876

Approval for a new manufacturing site located at Colorado MEDtech, Inc., Boulder, Colorado. The Gynecare Thermachoice Controller will be manufactured at this facility.

P970058/S015

3/4/03

180-Day

ImageChecker

R2 Technologies, Inc.

Sunnyvale, CA

94087

Approval for a new manufacturing facility located at R2 Technologies, Inc. Sunnyvale, California.

P980016/S031

3/6/03

180-Day

Model 7230 Marquis VR Single Chamber ICD System

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a move of the European Operations Center from Kerkrade, The Netherlands to Medtronic B.V., Heerleen, The Netherlands.

P980035/S013

3/26/03

180-Day

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

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic AT500 DDDRP Pacing System (Model AT501) and Model 9968 Software.  The Medtronic AT500 DDDRP Pacing System is 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. The Medtronic AT500 system is 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:  1) Various degrees of AV block to maintain the atrial contribution to cardiac output.  2) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.  Antitachycardia Pacing (ATP) is indicated for termination of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications.  Atrial rhythm management features such as Atrial Rate Stabilization (ARS) Atrial Preference Pacing (APP), and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in bradycardia patients with atrial septal lead placement and one or more of the above pacing indications.

P990015/S002

3/18/03

180-Day

GYNECARE INTERGEL Adhesion Prevention Solution

Lifecore Biomedical, Inc.

Chaska, MN

55318

Approval for changes to the labeling in response to adverse event reports of additional surgery, including hysterectomy, that occurred following post-operative pain, ascites, non-infectious peritonitis, and/or possible delayed clearance of GYNECARE INTERGEL.

P990037/S014

3/14/03

Special

Vascular Solutions Duett™ sealing device

Vascular Solutions, Inc.

Minneapolis, MN

55441

Approval for an additional incoming inspection requirement to measure the Outer Diameter (OD) of the distal end of the stopcock and to tighten the tolerance around the originally approved OD on the stopcock distal end.

P990038/S004

3/14/03

180-Day

DiaSorin HBsAg Confirmatory Test

DiaSorin, Inc.

Saluggia, Italy

Approval for use of a DiaSorin HBsAg confirmatory reagent to confirm ETI-MAK-2 PLUS repeatedly reactive samples, and use of a DiaSorin confirmatory reagent specifically in prenatal screening to confirm all ETI-MAK-2 PLUS repeatedly reactive samples in the absence of other HBV marker testing.  The device, as modified, will be marketed under the trade name DiaSorin HBsAg Confirmatory Test and is indicated for an in vitro neutralization assay for qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma samples (EDTA, heparin, and citrate) found to be repeatedly reactive for HBsAg by ETI-MAK-2 PLUS.  This assay has not been FDA-approved for the screening of blood or plasma donors.

P990074/S014

3/12/03

180-Day

McGhan Saline-Filled Breast Implants

Inamed Corporation

Santa Barbara, CA

93111

Approval to manufacture McGhan Saline-Filled Breast Implants, Styles 168, 163, 363LF, and 468 at Inamed Corporation’s facility located in Barreal de Heredia, Costa Rica.

P990086/S003

3/14/03

Panel

Healthtronics OssaTron®

Healthtronics Surgical Services, Inc.

Marietta, GA

30062

Approval for the Healthtronics OssaTron®.  The device is indicated for use for performing extracorporeal shock wave (ESW) treatment in patients with chronic lateral epicondylitis (tennis elbow) that has failed to respond to conservative treatment.  Chronic Lateral Epicondylitis is defined as lateral epicondylitis that has persisted for 6 months or more with a history of unsuccessful conservative treatment.

P000013/S001

3/17/03

Real-Time

Osteonics ABC/Trident Systems

Howmedica Osteonics Corporation

Allendale, NJ

07401

Approval for the following items:  1) Use of the Trident Acetabular System with V40 Alumina Heads and additional C-Taper Alumina Head sizes (and associated stems)  2) Use of the Trident Acetabular System with V40/C-Taper and Morse Taper Adapter Sleeves (and associated femoral stems)  3) Use of additional styles of Trident Acetabular Shells; and  4) Associated labeling changes due to modifications identified above.

P000018/S031

3/17/03

Special

Novoste™

Beta-Cath™ 3.5 System

Novoste Corp.

Norcross, GA

30093

Approval for an additional inspection step in the manufacturing process of the

β-Rail™ 3.5F Delivery Catheter.

P000025/S006

3/18/03

180-Day

MED-EL COMBI 40+ Cochlear Implant System with C40+, C40+S, or C40+GB Implants, and CIS PRP+/TEMPO+ Speech Processors

MED-EL Corporation

Durham, NC

27713

Approval for broadening the indication of the C40+ Cochlear Implant System to include children aged twelve months or older.

P000025/S008

3/25/03

Special

MED-EL COMBI 40+ Cochlear Implant System; MED-EL COMBI 40+ (Standard), COMBI 40+S (Compressed), and COMBI 40+ GB (Split) Cochlear Implant Electrode Arrays; Tempo+ and CIS-PRO+ Speech Processors

MED-EL Corporation

Durham, NC

27713

Approval for the following changes in the labeling: 

1) Informational statements regarding meningitis, the use of prophylactic antibiotics, and vaccinations 

2) Informational statements regarding electrostatic discharge (ESD) preventions.

P000043/S005

3/19/03

180-Day

TMx-2000 BPH Thermotherapy System

TherMatrx, Inc.

Northbrook, IL

60062

Approval to change the manufacturing site for the final product acceptance for the Rx-200 treatment catheter to Manufacturing and Research, Inc., Tucson, Arizona.

P000046/S006

3/18/03

180-Day

Staarvisc™ II, Shellgel™ and CoEase™ Sodium Hyaluronate Viscoelastics

Anika Therapeutics

Woburn, MA

01801

Approval for an additional method for endotoxin testing.

P000046/S007

3/12/03

180-Day

Staarvisc™ II, Shellgel™, and CoEase™ Sodium Hyaluronate Viscoelastics

Anika Therapeutics

Woburn, MA

01801

Approval for use of an alternate raw material source.

P010012/S007

3/21/03

180-Day

CONTAK CD

Guidant Corporation

St. Paul, MN

55112

Approval for changes to the patient handbooks.

P010012/S009

3/25/03

Real-Time

EASYTRAK 3 Pacing Lead

Guidant Corporation

St. Paul, MN

55112

Approval for Titanium Oxide-impregnated suture sleeve and is indicated for use with Guidant EASYTRAK leads.

P010015/S009

3/27/03

180-Day

InSync III Model 8042 Atrial Synchronous Biventricular Pacing Device

Medtronic, Inc.

Minneapolis, MN

55432

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

P010019/S002

3/19/03

Real-Time

NIGHT & DAY™ 30 Night Extended Wear Soft Contact Lens

CIBA Vision Corporation

Duluth, GA

30097

Approval for the following indication:  NIGHT & DAY™ soft contact lenses are also indicated for therapeutic use.  Use as a bandage to protect the cornea and to relieve corneal pain during the treatment of acute or chronic ocular pathologies such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery.  NIGHT & DAY™ soft contact lenses for therapeutic use can also provide optical correction during healing if required.

P010022/S002

3/18/03

Special

CoSeal™ Surgical Sealant

Cohesion Technologies, Inc.

Palo Alto, CA

94303

Approval for a labeling change to add a boxed warning regarding swell volumes of the sealant.

P010031/S003

3/27/03

180-Day

Medtronic® InSync Marquis™ Model 7277 Dual Chamber Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy and InSync Marquis™ Application Software Model 9983

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic InSync Marquis Model 7277 Dual Chamber Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy and InSync Marquis Application Software Model 9983 and for the system to be manufactured at Med Rel, Humacaco, Puerto, Rico, Medtronic, Europe S.A, Tolochenaz, Switzerland and Medtronic BV, Kerkrade, The Netherlands.

P010032/S007

3/5/03

180-Day

Rapid Programmer

Advanced Neuromodulation Systems, Inc.

Plano, TX

75024

Approval for the Rapid Programmer which is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

P010033/S003

3/17/03

Special

QuantiFERON-TB

Cellestis, Inc.

Valencia, CA

91355

Approval for labeling changes to the Instructions for Use that enhance the safe use of the QuantiFERON-TB by incorporating recommendations from the “CDC Guidelines for using the QuantiFERON-TB Test for Diagnosing Latent Mycobacterium tuberculosis Infection” (MMWR Dispatch, Vol. 51/December 18, 2002).

P010034/S002

3/7/03

180-Day

Second Look Computer-Aided Detection System

CADX Medical Systems, Inc.

Northborough, England

Approval for a manufacturing site located at Colorado Medtech, Inc., Boulder, Colorado.

P010038/S003

3/6/03

180-Day

iCAD

iCAD, Inc.

Tampa, FL

33634

Approval for a manufacturing site located at iCAD, Inc. Nashua, New Hampshire.

P010049/S005

3/12/03

Special

QuickSeal CCS Arterial Closure System

Sub-Q, Inc.

San Clemente, CA

92673

Approval for two labeling additions to the approved Premarket Approval Application.

P010050/S001

3/13/03

Real-Time

IMMULITE®,

IMMULITE® 1000 HBsAg,

Confirmatory and IMMULITE® 2000 HBsAg,

Confirmatory Kit

Diagnostic Products Corporation

Los Angeles, CA

90045

Approval for use of the IMMULITE®,
IMMULITE® 1000 HBsAg
Confirmatory on the IMMULITE® 1000 Automated Analyzer.

P010051/S001

3/13/03

Real-Time

IMMULITE®, IMMULITE® 1000 Anti-HBc IgM and IMMULITE® 2000 Anti-HBcIgM

Diagnostic Products Corporation

Los Angeles, CA

90045

Approval for use of the IMMULITE®, IMMULITE® 1000 Anti-HBc IgM on the IMMULITE® 1000 Automated Analyzer.

P010052/S001

3/13/03

Real-Time

IMMULITE®, IMMULITE® 1000 Anti-HBs and IMMULITE® 2000 Anti-HBs

Diagnostic Products Corporation

Los Angeles, CA

90045

Approval for use of the IMMULITE®, IMMULITE® 1000 Anti-HBs on the IMMULITE® 1000 Automated Analyzer.

P010053/S001

3/13/03

Real-Time

IMMULITE®, IMMULITE® 1000 Anti-HBc and IMMULITE® 2000 Anti-HBc

Diagnostic Products Corporation

Los Angeles, CA

90045

Approval for use of the IMMULITE®, IMMULITE® 1000 Anti-HBc on the IMMULITE® 1000 Automated Analyzer.

P020009/S006

3/12/03

180-Day

Express/Express2 MR and OTW Coronary Stent System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for an alternate facility located at Boston Scientific Ireland, Ltd. (BSIL), Galway, Ireland for the manufacture of the stent component of the stent system.

P020014/S001

3/6/03

Real-Time

Essure™ System

Conceptus, Inc.

San Carlos, CA

94070

Approval for a modified delivery catheter called the coil catheter and a modified split introducer.

P900056/S076

3/7/03

Rotablator Rotational Angioplasty System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Modification of the processing parameters within the same sterilization facility.

P950034/S023

3/25/03

Seprafilm® Adhesion Barrier and Seprafilm Procedure Pack

Genzyme Corporation

Cambridge, MA

02134

The return of distribution activities for Seprafilm® Adhesion Barrier and Seprafilm Procedure Pack to the Framingham, Massachusetts, manufacturing facility.

P990075/S010

3/7/03

Mentor Saline Filled Breast Implants

Mentor Corporation

Santa Barbara, CA

93111

Use of a laser to engrave the Mentor name, logo, device lot number, and device volume onto the patch on the shell of the saline filled breast implants.

P990075/S011

3/26/03

Mentor Saline Filled Breast Implants

Mentor Corporation

Santa Barbara, CA

93111

Change for alternative calendaring equipment and an alternative material supplier for the silicone sheeting.

P000018/S032

3/13/03

Novoste™ Beta-Cath™ 3.5F System

Novoste Corporation

Norcross, GA

30093

Alternate method of manufacture of the

Beta-Cath™ 3.5F System Flushing Adapter.

P000044/S003

3/20/03

Vitros® Immunodiagnostic Products HBsAg Reagent Pack and Calibrator

Ortho-Clinical Diagnostic, Inc.

Rochester, NY

14626

Addition of raw material supplier for uncoated microwells

P000052/S018

3/20/03

GALILEO® and GALILEO® III Intravascular Radiotherapy Systems

Guidant Corporation

Houston, TX

77054

Change in the manufacturing process for Guidant’s P-32 Source Wire.

P020009/S007

3/7/03

Express/Express2™ Coronary Stent System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Manufacturing change in the final cleaning procedure for the stent component of the Express/Express2™  Coronary Stent System.