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PMA Final Decisions Rendered for November 2002

P990069

11/27/02

ALERT® System (ALERT® Catheter, ALERT® Interface Cable, and ALERT® Companion™ with Software Version 1.08)

EPMed Systems, Inc.

West Berlin, NJ 08091

Approval for the ALERT System (ALERT Catheter, ALERT Interface Cable, and ALERT Companion with Software Version 1.08).  The ALERT System is indicated for use in patients who are candidates for transvenous electrical cardioversion for the treatment of atrial fibrillation.

P020004

11/6/02

EXCLUDER™ Bifurcated Endoprosthesis

W.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Approval for the EXCLUDER™ Bifurcated Endoprosthesis.  The EXCLUDER™ Bifurcated Endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysms (AAA) disease and who have appropriate anatomy as described: 

1) Adequate iliac/femoral access  2) Infrarenal aortic neck treatment diameter range of 19-26 mm and a minimum aortic neck length of 15 mm  3) Proximal aortic neck angulation ≤ 60 º 4) Iliac artery treatment diameter range of 8-13.5 mm and iliac distal vessel seal zone length of at least 10 mm.  The Aortic and Iliac Extender Endoprostheses are intended to be used after deployment of the EXCLUDER Bifurcated Endoprosthesis.  These extensions are intended to be used when additional length and/or sealing for aneurismal exclusion is desired.

P020011

11/7/02

VERSANT™ HCV RNA Qualitative Assay

Gen-Probe Inc.

San Diego, CA

92121

Approval for the VERSANT™ HCV RNA Qualitative Assay.  The device is indicated for:  The VERSANT™ HCV RNA Qualitative Assay is an in vitro nucleic acid amplification assay for the detection of hepatitis C virus (HCV) RNA in human plasma (EDTA, sodium heparin, sodium citrate, and ACD) or serum.  The VERSANT™ HCV RNA Qualitative  Assay is indicated for use with fresh or frozen specimens from the following populations: individuals with antibody evidence of HCV infection with evidence of liver disease, and individuals suspected to be actively infected with HCV with antibody evidence, and individuals at risk for HCV infection with antibodies to HCV.  Detection of HCV RNA is evidence of active HCV infection.

P020014

11/4/02

Essure™ System

Conceptus, Inc.

San Carlos, CA

94070

Approval for the Essure™ System.  The device is indicated for permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.

P830037/S047

11/26/02

Real-Time

FreshLook® Radiance Spherical and Toric (phemfilcon A) Soft Contact Lenses

CIBA Vision Corporation

Duluth, GA

30097

Approval for an additional colorant to be used in the colorant process and a revision to the labeling to move the statement “the lens acts to enhance or alter the apparent color of the eye” from the Actions section of the package insert to the Indications section.  The device, as modified, will be marketed under the Freshook® trade name with the following indications:  Vision Correction Spherical: FreshLook® spherical (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.  Toric 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 Daily Wear or Extended Wear in not-aphakic persons from 1 to 7 days between removal for cleaning an disinfection or disposal, as recommended by the eye care professional or for Daily Wear in aphakic persons.  The eye care professional may prescribe the lens in either the single-use disposable wear or for frequent replacement with cleaning, disinfection and scheduled replacement.  When prescribed for frequent replacement, 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.

P850048/S017

11/27/02

180-Day

Access Hybritech PSA on the Access 2 Immunoassay Analyzer

Beckman Coulter, Inc.

Chaska, MN

55318

Approval for the Access Hybritech PSA on the Access 2 Immunoassay Analyzer.  The device is indicated for:  The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) in human serum using the Access Immunoassy Systems.  The device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older.  Prostate biopsy is required for diagnosis of cancer.  The device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.

P860003/S041

11/25/02

180-Day

UVAR XTS Photopheresis System

Therakos, a Johnson & Johnson Company

Exton, PA

19341

Approval for a new manufacturing facility located at Mack Molding Company, Arlington, Vermont.  The facility will manufacture the XTS Instrument and XT20 light assembly.

P860019/S179

11/20/02

180-Day

Maverick2™ Monorail™ PTCA Catheter

Boston Scientific SCIMED, Inc.

Maple Grove, MN

55311

Approval for the Maverick2™ Monorail™ PTCA Catheter.  The device, as modified, will be marketed under the trade name Maverick2™ Monorail™ PTCA Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.  The Maverick2™ balloon catheter (2.25 – 4.00 mm) is also indicated for the post delivery expansion of balloon expandable stents.

P860019/S186

11/21/02

135-Day

Maverick™ OTW, Maverick™ Monorail ™& Maverick2™ Monorail™ PTCA Catheters

Boston Scientific SCIMED, Inc.

Maple Grove MN

55311

Approval for a modification of the laser welding process for the Maverick™ OTW, Maverick™ Monorail ™& Maverick2™ Monorail™ PTCA Catheters.

P860019/S189

11/6/02

Special

Boston Scientific/SCIMED PTCA Catheters: NC Monorail™,

NC Big Ranger ™, NC Ranger™ 15 mm, NC Ranger™ 22/25/30 mm,

NC Ranger™ 16/18 mm and NC Ranger™ 9mm

Boston Scientific SCIMED, Inc.

Maple Grove MN

55311

Approval for an additional instruction in the Directions for Use Manual in order to enhance safe device use.

P860019/S190

11/25/02

180-Day

SCIMED ACE, ACE 1 cm Tip, Long ACE, Graft ACE, Pivot, Trapper, Surpass, and Remedy PTCA Catheters

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for an alternate sterilization facility located at Cosmed Group, Inc., Coventry, Rhode Island.

P900009/S014

11/18/02

Real-Time

Exogen 2000+ Sonic Accelerated Fracture Healing System

Smith and Nephew, Inc.

Memphis, TN

38116

Approval for labeling changes to the Physician’s Instructions for Use.

P920014/S016

11/6/02

Panel

Thoratec HeartMate Sutures Not Applied Vented Electric Left Ventricular Assist System (SNAP VE LVAS)

Thoratec Corporation

Pleasanton, CA

94588

Approval for an expanded Indication for Use for the Thoratec HeartMate SNAP VE LVAS.  The device 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 of the hospital.

P940022/S026

11/1/02

Real-Time

CLARION® CII Bionic Ear System (Adult)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for the following changes to the postmarket study protocol:  1) Use of only the PB-K Test to determine candidacy in children 4 years through 17 years of age at time of implant.  2) Substitution of the PB-K Test for the ESP Test as an outcome measure.  3) Division of the youngest age group into two groups. 

4)  Additional inclusion/exclusion criteria for adults and children.

P940022/S027

11/6/02

Real-Time

CLARION® CII Bionic Ear System (Adult)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for a revision to the Package Insert (Document Number 9196252-001) that modified the percentage of patients who preferred High Resolution Sound Processing to conventional sound processing.  This modification is based on updated data received from patients at the 12-month follow-up visit which showed that three of the five patients who originally preferred their conventional strategy at the three-month experimental strategy visit switched their preference to HiRes.  Thus, 48 of 50 patients (96%) ultimately preferred HiRes.

P950005/S015

11/13/02

180-Day

NAVISTAR™ Deflectable Tip Diagnostic/Ablation Catheters

Biosense Webster

Diamond Bar, CA

91765

Approval for the sterilization facility located at Cosmed of California, San Diego, California.

P960011/S007

11/1/02

180-Day

BioLon

Bio-Technology General Corp.

Iselin, NJ

08830

Approval for a new sterilization facility located at Mediplast Israel, Ltd., Yavnem, Israel

P960043/S042

11/12/02

Real-Time

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

Perclose, Inc.

Redwood City, CA

94063

Approval for expanding the Indications for Use of the Closer A-T 6 Fr. SMC System to include 7 and 8 Fr. sheath sizes and to change the labeling to include <0.038” guidewires.

P960058/S026

11/1/02

Real-Time

CLARION® CII Bionic Ear System (Pediatric)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for the following changes to the postmarket study protocol:  1) Use of only the PB-K Test to determine candidacy in children 4 years through 17 years of age at time of implant.  2) Substitution of the PB-K Test for the ESP Test as an outcome measure.  3) Division of the youngest age group into two groups. 

4)  Additional inclusion/exclusion criteria for adults and children.

P960058/S027

11/6/02

Real-Time

CLARION® CII Bionic Ear System (Pediatric)

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for a revision to the Package Insert (Document Number 9196252-001) that modified the percentage of patients who preferred High Resolution Sound Processing to conventional sound processing.  This modification is based on updated data received from patients at the 12-month follow-up visit which showed that three of the five patients who originally preferred their conventional strategy at the three-month experimental strategy visit switched their preference to HiRes.  Thus, 48 of 50 patients (96%) ultimately preferred HiRes.

P960058/S028

11/25/02

180-Day

CLARION® CII Bionic Ear™ System HiFocus Electrode

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for minor changes to the HiFocus Electrode to better facilitate the packing of the cochleostomy and electrode insertion.  Specifically, the changes are to move the offset region approximately 3 mm further away from the current location.

D970003/S018

11/4/02

Real-Time

INSIGNIA Entra and Plus Implantable Pacemaker System

Guidant Corporation

St. Paul, MN

55112

Approval for modifications to the INSIGNIA Entra and Plus Implantable Pacemaker Systems as follow:  1) Disabling VRR in Entra devices; and  2) Correcting a math engine anomaly.

P970037/S001

11/27/02

Special

AutoDELFIA™ hAFP kit

PerkinElmer Life Sciences, Inc. / PerkinElmer Wallac, Inc.

3985 Eastern Road

Norton, OH

44203

Approval for labeling changes to the patient and physician brochures and 3 versions of the package insert for the laboratory.

P970038/S005

11/27/02

180-Day

Access Hybritech free PSA on the Access 2 Immunoassay Analyzer

Beckman Coulter, Inc.

Chaska, MN

55318

Approval for the Access Hybritech free PSA on the Access 2 Immunoassay Analyzer.  The device is indicated for:  The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (free PSA) in human serum using the Access Immunoassay Systems.  Access Hybritech free PSA is intended to be used with Hybritech (total) PSA to calculate the ratio of free PSA to total PSA expressed as a percentage (percent free PSA).  Percent free PSA as measured by the Hybritech assays is indicated for use as an  aid in distinguishing prostate cancer from benign prostatic conditions, when used in conjunction with Hybritech (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/ml with digital rectal examination findings that are not suspicious for cancer.  Prostatic biopsy is required for diagnosis of cancer.

P970043/S011

11/7/02

180-Day

LADARVision 4000 Excimer Laser System

Alcon Laboratories, Inc.

Orlando, FL

32826

Approval for a manufacturing site located at Alcon, Cork, Ireland.

P970051/S021

11/22/02

180-Day

Nucleus 24 Cochlear Implant System with Contour Softip Electrode

Cochlear Americas

Englewood, CO

80112

Approval for minor design modification to the Contour 24 cochlear implant electrode.  The device, as modified, will be marketed under the trade name Contour Softip Electrode.

P970061/S018

11/25/02

180-Day

RADIUS Coronary Stent with Delivery System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for an alternate sterililzation facility located at Cosmed Group, Inc.

Coventry, Rhode Island.

P980023/S009

11/25/02

180-Day

Kainox RV-S and Kainox VCS ICD Leads

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the Kainox RV-S active fixation, single shock coil ICD lead and the Kainox VCS single shock coil ICD lead for use as an adjunct to modify the shock configuration of ICD systems.  Together with legally marketed BIOTRONIK ICDs, these lead systems provide the patient with a system that is capable of detecting and treating ventricular tachyarrhythmias.

P990017/S036

11/8/02

180-Day

Ancure System

Guidant Corporation

Menlo Park, CA

94025

Approval for an additional sterilization site located at Steris Isomedix Services, Vega Alta, Puerto Rico.

P990018/S003

11/6/02

Real-Time

Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens

Menicon Co., Ltd.

Aichi, Japan

460-0006

Approval for Alcon® Unique-pH Multi-Purpose Solution as an alternate wet shipping solution for the Menicon Z™ Rigid Gas Permeable Contact Lens.

P990020/S009

11/21/02

180-Day

The AneuRx™ Stent Graft with Xpedient Delivery System

Peripheral Technologies

Santa Rose, CA

95407

Approval for the Xpedient Delivery System.  The device, as modified, will be marketed under the trade name AneuRx™ Stent Graft with Expedient Delivery System and is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms having:  1) Infrarenal, non-aneurysmal, neck length of greater than 1 cm at the proximal and distal ends of the aneurysm and an inner vessel diameter approximately 10-20% smaller than the labeled device diameter:  2) Morphology suitable for endovascular repair;  3) One of the following: a) Aneurysm diameter > 5 cm;  b) Aneurysm diameter of 4-5 cm which has also increased in size by 0.5 cm in the last 6 months; or  c) Aneurysm which is twice the diameter of the normal infrarenal aorta.

P990025/S005

11/13/02

Real-Time

NAVISTAR™ Deflectable Tip Diagnostic/Ablation Catheters

Biosense Webster

Diamond Bar, CA

91765

Approval for the sterilization facility located at Cosmed of California, San Diego, California.

P990028/S005

11/25/02

Special

FocalSeal-L Synthetic Absorbable Sealant

Genzyme Biosurgery

Cambridge, MA

02139

Approval for the addition of a box around the Contraindications section of the Instructions for Use for FocalSeal-L Sealant.

P990034/S003

11/08/02

180-Day

Isomed Implantable Constant-Flow Infusion Pump (Model 8472)

Medtronic Neurological

Minneapolis, MN

55432

Approval for a new manufacturing, packaging and sterilization facility at Medtronic Neurological and Spinal Division, Columbia Heights, Minnesota.

P990042/S004

11/14/02

180-Day

DiaSorin ETI-AB-AUK PLUS Assay

DiaSorin, Inc.

Baldwin, MD

21013

Approval for use of ETI-AB-AUK PLUS assay on the Biochem Immunosystems Labotech/ETI-LAB automated instrument.

P990053/S008

11/25/02

180-Day

OxiFirst™ Fetal Oxygen Saturation Monitoring System

Tyco Healthcare /Nellcor  Puritan Bennett

Pleasanton, CA

94588

Approval for a new manufacturing facility located at Nellcor Puritan Bennett, Inc., Minneapolis, Minnesota.  Factory service operations for the N-400 Fetal Oxygen Saturation Monitors will be performed at this facility.

P990053/S009

11/25/02

180-Day

OxiFirst™ Fetal Oxygen Saturation Monitoring System

Tyco Healthcare /Nellcor  Puritan Bennett

Pleasanton, CA

94588

Approval for a new manufacturing facility located at Nellcor Puritan Bennett, Inc., Minneapolis, Minnesota.  This facility will perform manufacturing of the FSp02-PM Fetal Patient Modules.

P990053/S010

11/15/02

Special

OxiFirst™ Fetal Oxygen Saturation Monitoring System

Tyco Healthcare /Nellcor  Puritan Bennett

Pleasanton, CA

94588

Approval for modifications to the labeling.

P990066/S015

11/21/02

180-Day

Senographe 2000D Full Field Digital Mammography System

General Electric Medical Systems

Milwaukee, WI

53188

Approval for modifications to the approved system to permit use of an optional contrast enhancement algorithm (Dynamic Range Management) introduction of new display protocols and minor changes in the display scenarios, and addition of keyboard shortcuts for window width/window level settings.  The supplement also includes changes in the labeling to reflect the modifications listed above.

P990081/S001

11/27/02

180-Day

PATHWAY HER2 (Clone CB11)

Ventana Medical Systems, Inc.

Tucson, AZ

85737

Approval for a new manufacturing site located at Ventana Medical Systems, Tucson, Arizona.

P000018/S026

11/13/02

Special

Novoste™ Beta-Cath™ 3.5F System

Novoste Corp.

Norcross, GA

30093

Approval for modifications to the User’s Manual, User’s Guide and customer training to include additional information on scenarios where the β-Rail 3.5F Delivery Catheter tip may be subjected to excessive force and the techniques for avoiding and/or resolving these scenarios.

P000052/S012

11/18/02

180-Day

GALILEO® III Intravascular Radiotherapy System

Guidant Corporation

Houston, TX

77054

Approval of the post-approval study for the device.

P010013/S003

11/25/02

180-Day

NovaSure Impedance Controlled Endometrial Ablation System

Novacept, Inc.

Palo Alto, CA

94303

Approval for a new manufacturing facility located at Sanmina-SCI Corporation, San Jose, California.  The Novacept RF Controller will be manufactured at this facility.

P010038/S002

11/20/02

Real-Time

iCAD

iCAD, Inc.

Tampa, FL

33634

Approval for a device name change from “MammoReader” to “iCAD.”

P010049/S003

11/27/02

180-Day

QuickSeal CCS Arterial Closure System

Sub-Q, Inc.

San Clemente, CA

92673

Approval for an alternate manufacturing facility to perform device assembly and packaging, located at Sub-Q, Inc., San Clemente, California.

P790019/S016

11/6/02

Abbott HAVAB-M™ EIA (List Number 9843)

Abbott Laboratories, Inc.

Abbott Park, IL

60064

Changes to: 

1) Replace lyophilized goat anti-human IgM purchased from Litton Bionetics with non-lyophilized goat anti-human IgM purchased from Jackson Immuno Research. 

2) Replace rheophoresis testing for goat anti-human IgM (antibody) identity/specificity with immunoelectro-phoresis (IEP) testing.  3) Replace HAVAB-M RIA (radioimmunoassay) antibody bead coat efficacy testing with small-scale antibody dilution factor determination and confirmation testing using HAVAB-M EIA (enzyme immunoassay) to establish the optimal dilution factor of the goat anti-human IgM antibody to be used for full-scale production bead coating.

P890014/S004

11/8/02

DiaSorin ETI-HA-IGMK PLUS

DiaSorin S.r.l.

Saluggia, Italy

13040

Change in the vendor of the bulk solution used in the preparation of the Chromagen/

Substrate kit reagent with an accompanying change in the Stop Solution concentration.

P890019/S007

11/8/02

DiaSorin ETI-AB-HAVK PLUS

DiaSorin S.r.l.

Saluggia, Italy

13040

Change in the vendor of the bulk solution used in the preparation of the Chromagen/

Substrate kit reagent with an accompanying change in the Stop Solution concentration.

P990038/S003

11/8/02

DiaSorin ETI-MAK-2 PLUS

DiaSorin S.r.l.

Saluggia, Italy

13040

Change in the vendor of the bulk solution used in the preparation of the Chromagen/

Substrate kit reagent with an accompanying change in the Stop Solution concentration.

P990041/S002

11/8/02

DiaSorin ETI-AB-EBK PLUS

DiaSorin S.r.l.

Saluggia, Italy

13040

Change in the vendor of the bulk solution used in the preparation of the Chromagen/

Substrate kit reagent with an accompanying change in the Stop Solution concentration.

P990042/S005

11/26/02

DiaSorin ETI-AB-AUK PLUS

DiaSorin S.r.l.

Saluggia, Italy

13040

Change in the vendor of the bulk solution used in the preparation of the Chromagen/

Substrate kit reagent with an accompanying change in the Stop Solution concentration.

P990043/S003

11/8/02

DiaSorin ETI-EBK PLUS

DiaSorin S.r.l.

Saluggia, Italy

13040

Change in the vendor of the bulk solution used in the preparation of the Chromagen/

Substrate kit reagent with an accompanying change in the Stop Solution concentration.

P990044/S002

11/8/02

DiaSorin ETI-CORE-IGMK PLUS

DiaSorin S.r.l.

Saluggia, Italy

13040

Change in the vendor of the bulk solution used in the preparation of the Chromagen/

Substrate kit reagent with an accompanying change in the Stop Solution concentration.

P990045/S003

11/8/02

DiaSorin ETI-AB-COREK PLUS

DiaSorin S.r.l.

Saluggia, Italy

13040

Change in the vendor of the bulk solution used in the preparation of the Chromagen/

Substrate kit reagent with an accompanying change in the Stop Solution concentration.

P000011/S007

11/14/02

BiodivYsio® OC and SV Over-the-Wire Stent Delivery Systems

Abbott Vascular Devices

Redwood City, CA

94063

Change in vendor for the balloon material.

P020009/S002

11/5/02

Express/

Express2™ Coronary Stent System

Boston Scientific/ SCIMED

Maple Grove, MN

55311

Changing the quality control acceptance criteria for the stainless steel tubing (raw material) used to manufacture the stent component for the devices.