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PMA Final Decisions Rendered for September 2004

P030028

9/10/04

ARTISAN® (Model 206 and 204) Phakic Intraocular Lens (PIOL) Verisyse™ (VRSM5US and VRSM6US) Phakic Intraocular Lens (PIOL)

Ophtec BV

Boca Raton , FL

33487

Approval for the ARTISAN® (Model 206 and 204) Phakic Intraocular Lens, also known as the Verisyse™ (VRSM5US and VRSM6US) Phakic Intraocular Lens to be distributed by Advance Medical Optics. The device is indicated for: 1) the reduction or elimination of myopia in adults with myopia ranging from -5 to -20 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane and whose eyes have an anterior chamber depth greater than or equal to 3.2 millimeters; and, 2) patients with documented stability of refraction for the prior 6 months, as demonstrated by spherical equivalent change of less than or equal to 0.50 diopters.

P040029

9/29/04

JSZ Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear

Szabocsik and Associates

Chicago , IL

60601

Approval for the JSZ Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear. The lenses are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear for the temporary reduction of myopia up to 5.00 diopters with eyes having astigmatism up to 1.50 diopters. The lenses may only be disinfected using a chemical disinfection system. NOTE: To maintain the Orthokeratology effect of myopia reduction, overnight lens wear must be continued on a prescribed schedule. Failure to do so can affect daily activities (e.g., night driving), visual fluctuations and changes in intended correction.

P870072/S029

9/13/04

180-Day

Thoratec® Paracorporeal Ventricular Assist Device (PVAD) System and TLC-II Portable VAD Driver

Thoratec Corporation

Pleasanton , CA

94588

Approval for the post approval study home-discharge registry protocol.

P890003/S075

9/15/04

Real-Time

Model 9879 Software for Thera/Thera-i/Prodigy Devices, Model 9849 Software for the Legacy II/Visa Devices, Model 9847 Software for 7968-i Thera DR Device and Model 9980 Software for the InSync 8040 Device.

Medtronic, Inc.

Minneapolis , MN

55432

Approval to update the longevity projections for the Model 9879 Software for Thera/Thera-i/Prodigy Devices, Model 9849 Software for the Legacy II/Visa Devices, Model 9847 Software for 7968-i Thera DR Device and Model 9980 Software for the InSync 8040 Device.

P890023/S016

9/24/04

Real-Time

HYDROGENICS® 2.0 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lens for Extended Wear

Ocular Sciences, Inc.

Rockville , MD

20850

Approval for a minor design change to incorporate the aspheric version of the lens; a minor edge configuration change; and minor labeling changes. The device, as modified, will be marketed under the trade name HYDROGENICS® 2.0 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lens for Extended Wear and is indicated as follows: HYDROGENICS® 2.0 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in persons with not-aphakic, non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters or less that does not interfere with visual acuity. They are also indicated for extended wear up to 7 days/6nights. The eye care practitioner may prescribe the contact lenses for either single use disposable wear or for frequent replacement wear. When prescribed for frequent replacement/ planned replacement, the lenses may be disinfected using a chemical or hydrogen peroxide disinfecting system. The device helps protect against transmission of harmful UV radiation to the cornea and into the eye.

P910007/S011

9/27/04

Real-Time

Abbott AxSYM® Total PSA Assay

Abbott Laboratories

Abbott Park , IL

60064

Approval of the following modifications to the Abbott AxSYM® Total PSA Assay: 1) Change the functional sensitivity claim to 0.06 ng/mL 2) Addition of Flomax to the Analytical Specificity section of the package insert 3) Minor labeling changes to the package insert for the purpose of clarification, updates and conformation to requirements of the European Community Directives. The AxSYM® Total PSA assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement 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. Prostatic biopsy is required for diagnosis of cancer. 2) As an adjunctive test to aid in the management of prostate cancer patients.

P910066/S019

9/10/04

180-Day

OL1000, OL1000 SC and SpinaLogic Bone Growth stimulators

DJ Orthopedics, LLC/Regentek

Tempe , AZ

85281

Approval for 1) Change in the labeling to reflect the new company ownership from OrthoLogic to DJ Orthopedics/ Regentek; 2) Addition of a product specifications section to all manuals to comply with Canadian Standards Association. (applies to OL series and SpinaLogic manuals); 3) Addition of reference section (applies to SpinaLogic manuals only); and 4) In Risk and Benefits section of the SpinaLogic Patient Manual, revision the statement “…20% greater chance of back surgery healing” to “…the benefit of the SpinaLogic is that you have a greater chance of your back surgery healing if you use the device every day than if you don not use it.”

P930038/S040

9/13/04

Real-Time

Angio-Seal™ Vascular Closure Device STS PLUS, models 610130 and 610131

St. Jude Medical, Inc.

Minnetonka , MN

55345

Approval for a new 9 hole, hour-glass shape collagen sponge and a coated suture with minor changes to the carrier tube to incorporate the collagen sponge changes. The device, as modified, will be marketed under the trade name Angio-Seal™ Vascular Closure Device STS PLUS, models 610130 (6 Fr.) and 610131 (8 Fr.).

P960043/S056

9/10/04

Real-Time

Gated Suture Trimmer Accessory

Abbott Vascular Devices

Redwood City , CA

94063

Approval for modifications to the Gated Suture Trimmer accessory, specifically, overmolding the Tip-Sheath profile and increasing the diameter of the sheath to match the new tip diameters.

P960052/S009

9/24/04

180-Day

DERMABOND Topical Skin Adhesive

Closure Medical Corporation

Raleigh , NC

27616

Approval for an additional sterilization facility and to another known method of sterilization located at Sterigenics (formerly IBA/Griffith), Charlotte , North Carolina .

D970003/S029

9/28/04

Real-Time

INSIGNIA I Entra and INSIGNIA I Plus Implantable Pacemaker System

Guidant Corporation

St. Paul , MN

55112

Approval for model 2892 Programmer Application Software Versions 1.24.

P980007/S005

9/10/04

Real-Time

Abbott AxSYM® Free PSA Assay

Abbott Laboratories

Abbott Park , IL

60064

Approval for the addition of Flomax to the Analytical Specificity section of the package insert and minor labeling changes to the Abbott AxSYM® Free PSA Assay for the purpose of clarification, updates and conformation to requirements of the European Community Directives. The device, as modified, will be marketed under the same trade name AxSYM® Free PSA Assay and is indicated as follows: The AxSYM® Free PSA Assay 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.

P980023/S017

9/30/04

Kentrox RV-S Steroid and Kentrox SL-S Steroid Implantable Cardioverter Defibrillator (ICD) Leads

Biotronik, Inc.

Lake Oswego , OR

97035

Approval for addition of a steroid collar to single coil and dual coil lead versions, and modifications to the conductor coil and fixation helix.

P980044/S002

9/10/04

180-Day

SUPARTZ®

SEIKAGAKU Corporation

Ibaraki , Japan

318

Approval for addition of a plastic syring barrel with luer lock, in addition to the existing glass syringe barrel product.

P990030/S005

9/13/04

180-Day

VITAGEL™ Surgical Hemostat

Cohesion Technologies

Palo Alto , CA

94303

Approval for a new trade name for the device previously known as the CoStasis/DynaStat Surgical Hemostat: The device, as modified, will be marketed under the trade name VITAGEL™ Surgical Hemostat and is indicated for use in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

P000009/S013

9/17/04

Real-Time

Programmer Software A-K00.2.U in the Lexos, Belos and Cardiac Airbag Implantable Cardioverter Defibrillators

BIOTRONIK, Inc.

Lake Oswego , OR

97035

Approval for the use of the Programmer Software A-K00.2.U in the Lexos, Belos and Cardiac Airbag Implantable Cardioverter Defibrillators.

P000014/S009

9/27/04

Real-Time

VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, VITROS Immunodiagnostic Products Anti-HBs Calibrators

Ortho-Clinical Diagnostics

Rochester , NY

14626

Approval for a change from the qualitative detection of total anti-HBs in human serum to a quantitative detection of total anti-HBs in human serum. The device, as modified, will be marketed under the trade name VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and VITROS Immunodiagnostic Products Anti-HBs Calibrators. The VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack is indicated for: “The quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum using the VITROS ECi/ECiQ Immunodiagnostic System. Assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection for individuals prior to or following HBV vaccination, or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis, in whom etiology is unknown.” The VITROS Immunodiagnostic Products

Anti-HBs Calibrators is indicated for: “For use in the calibration of the VITROS ICi/ECiQ Immunodiagnostic System for the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum using the

VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack.”

P000049/S015

9/13/04

Special

CardioSEAL® Septal Occlusion System with Qwik Load

NMT Medical

Boston , MA

02210

Approval to modify the Patient Information Card to include a revised MRI compatibility statement that specifies that the compatibility testing was performed with a 1.5 Tesla magnetic field.

P010012/S026

9/14/04

Panel

CONTAK CD (Model 1823), CONTAK CD 2 (Models H115 and H119), RENEWAL (Model H135), RENEWAL 3 (Models H170, H175, H177, and H179)

Guidant Corporation

St. Paul , MN

55112

Approval for the CONTAK CD, CONTAK CD 2, RENEWAL, and RENEWAL 3 devices. These devices are indicated for patients with moderate to severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction (EF ≤ 35%) and QRS duration ≥ 120 ms.

P010013/S010

9/9/04

Special

NovaSure® Impedance Controlled Endometrial Ablation System

Cytyc Surgical Products

Palo Alto , CA

94303

Approval for labeling changes.

P010015/S014

9/15/04

Real-Time

Model 9879 Software for Thera/Thera-i/Prodigy Devices, Model 9849 Software for the Legacy II/Visa Devices, Model 9847 Software for 7968-i Thera DR Device and Model 9980 Software for the InSync 8040 Device.

Medtronic, Inc.

Minneapolis , MN

55432

Approval to update the longevity projections for the Model 9879 Software for Thera/Thera-i/Prodigy Devices, Model 9849 Software for the Legacy II/Visa Devices, Model 9847 Software for 7968-i Thera DR Device and Model 9980 Software for the InSync 8040 Device.

P010019/S003

9/27/04

180-Day

O 2 Optix™ (lotrafilcon B) and Focus® Night and Day® (lotrafilcon A) Soft Contact Lenses for Extended Wear

Ciba Vision Corporation

Duluth , GA

30097

Approval for 1) a modification to the lotrafilcon A material to market lotrafilcon B contact lenses with an indication for up to 6 nights of extended wear; 2) incorporation of a light blue handling tint, copper phthalocyanine, to both the lotrafilcon A and lotrafilcon B lens materials; and 3) a labeling change for lotrafilcon A lenses to allow for use with enzymatic cleaners. The lotrafilcon B lens will be marketed under the trade name O 2 Optix™ (lotrafilcon B) Soft Contact Lenses for Extended Wear and is indicated for the following: O 2 Optix™ (lotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. O 2 Optix™ Toric (lotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to 6.00 D or less of astigmatism. O 2 Optix™ Progressive (lotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have up to approximately 1.50 D of astigmatism. O 2 Optix™ Progressive Toric (lotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 0.75 to 2.75 D of refractive and/or corneal astigmatism. The lenses may be prescribed for daily wear or extended wear for up to 6 nights of continuous wear with removal for disposable, or cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional. There will be no change to the previously approved indications for use or conditions of approval for the lotrafilcon A lenses marketed under the brand name Focus® Night and day® for up to 30 nights of continuous wear.

P010038/S008

9/1/04

180-Day

Second Look® Digital Computer-aided Detection System

iCAD, Inc.

Beavercreek , OH

45431

Approval for the use of the Second Look Digital Computer-aided Detection System with the Hologic Lorad Selenia full-field digital mammographic system. The device, as modified, will be marketed under the trade name Second Look Digital Computer-aided Detection System and is indicated for: The second Look Digital Computer-aided Detection System is intended to identify and mark regions of interest on screening and diagnostic mammograms from the Hologic Lorad Selenia full-field digital mammographic system to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.

P010068/S004

9/10/04

Real-Time

Navistar™ DS 8 mm Deflectable Diagnostic/Ablation Catheter and Celsius™ DS 8 mm Deflectable Diagnostic/Ablation Catheter

Biosense Webster, Inc.

Diamond Bar , CA

91765

Approval for an alternative sterilization method (i.e., EO express for biological indicator release) for the Navistar™ DS 8mm Deflectable Diagnostic/Ablation Catheter and Celsius™ DS 8 mm Deflectable Diagnostic/Ablation Catheter.

P020047/S003

9/10/04

180-Day

MULTI-LINK MINI VISION® Coronary Stent System

Guidant Corporation

Santa Clara , CA

95054

Approval for the new product line, the MULTI-LINK MINI VISION Coronary Stent System. The device is indicated for improving coronary luminal diameter in patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (length ≤25 mm) with reference vessel diameters from 2.0 to 2.5 mm.

P020047/S004

9/10/04

180-Day

MULTI-LINK VISION Coronary Stent System – 2.75 mm

Guidant Corporation

Santa Clara , CA

95054

Approval for the 2.75 mm line extension for the MULTI-LINK VISION® Coronary Stent System. The device is indicated for improving coronary luminal diameter in patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (Length <=25 mm) with reference vessel diameters of 2.75 mm.

P030002/S002

9/29/04

Special

CrystaLens™ Model AT-45 Multipiece Silicone Posterior Chamber Accommodating Intraocular Lens (IOL)

Eyeonics, Inc.

Aliso Viejo , CA

92656

Approval to modify the device description in the physician labeling.

P030006/S002

9/17/04

Real-Time

Celsion Prolieve™ Thermodilatation System

Celsion Corporation

Columbia , MD

21046

Approval for software modifications including adjustment of tolerance limits. The device, as modified, will be marketed under the trade name Prolieve Thermodilation System (Prolieve). Prolieve is a transurethral microwave therapy device that provides a non-surgical, minimally invasive procedure for the treatment of symptomatic BPH 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) is typically indicated.

P040012/S001

9/24/04

180-Day

ACCULINK™ Carotid Stent System and RX ACCULINK™ Carotid Stent System

Guidant Corporation

Santa Clara , CA

95054

Approval of the post-approval study for the device.

P870024/S044

9/24/04

Paflufocon D – Rigid Gas Permeable Contact Lenses

Paragon Vision Sciences

Mesa , AZ

85204

Modification of a specific process of manufacture to reduce the hydration time and improve the comfort for the contact lens user.

P890003/S076

9/22/04

Vitatron Legacy 11 DR

Medtronic, Inc.

Minneapolis , MN

55432

Change in the sterilization process.

P900033/S012

9/17/04

INTEGRA Dermal Regeneration Template

Integra Lifesciences Corporation

Plainsboro , NJ

08536

Extension of the allowed holding time for one of the manufacturing processes.

P910007/S012

9/10/04

Abbott ARCHITECT® Total PSA

Abbott Laboratories

Abbott Park , IL

60064

Changes to the method for addition of MAK-33 to the Anti-PSA Coated Microparticles component of the Reagent Pack for the Abbott ARCHITECT® Total PSA.

P910073/S047

9/13/04

Lead Adapters Model 6024

Guidant Corporation

St, Paul , MN

55112

Change in the supplier that provides the mold release coating that is used on the sleeve of the lead adapters to prevent the bonding of the silicon sleeve to itself.

P970012/S016

9/22/04

Medtronic Kappa 400 Series Pacemakers

Medtronic, Inc.

Minneapolis , MN

55432

Change in the sterilization process.

D970012/S024

9/21/04

Model 700 Inflatable Penile Prosthesis

American Medical Systems, Inc.

Minnetonka , MN

55343

Change in vendor for the silicone rubber tubing that serves as a reservoir standpipe for the device.

P980007/S006

9/10/04

Abbott ARCHITECT® Free PSA

Abbott Laboratories

Abbott Park , IL

60064

Changes to the method for addition of MAK-33 to the Anti-PSA Coated Microparticles component of the Reagent Pack for the Abbott ARCHITECT® Free PSA.

P980016/S045

9/22/04

Marquis VR, DR/Maximo/ Maximo DR / Intrinsic 30/Intrinsic

Medtronic, Inc.

Minneapolis , MN

55432

Change in the sterilization process.

P980035/S039

9/22/04

Kappa 700, 800, 900/Sigma/EnPulse

Medtronic, Inc.

Minneapolis , MN

55432

Change in the sterilization process.

P010031/S016

9/22/04

InSync Marquis/InSync III (Marquis)/InSync II (Marquis)/InSync II (Protect)/ InSync Maximo/Prodigy DR

Medtronic, Inc.

Minneapolis , MN

55432

Change in the sterilization process.

P020023/S010

9/17/04

Restylane Injectable Gel

Q-Med Scandinavia, Inc.

Princeton , NJ

08540

Change of location for a manufacturing process.