P000013

2/3/03

Osteonics® ABC System and Trident™ System

Howmedica Osteonics Corporation

Rutherford, NJ

07070

Approval for the Osteonics® ABC System and Trident™ System.  These devices are indicated for patients requiring primary total hip arthroplasty due to painful disabling joint disease of the hip resulting from non-inflammatory degenerative arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant).

P010001

2/3/03

Ceramic TRANSCEND® Hip Articulation System

Wright Medical Technology

Arlington, TN

38002

Approval for the Ceramic TRANSCEND® Hip Articulation System.  The device is indicated for primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.

P790017/S078

2/4/03

180-Day

Stormer Balloon Dilatation Catheter with Zipper Delivery

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Approval for manufacturing changes to the Stormer Balloon Dilatation Catheter with Zipper Delivery.

P850020/S016

2/12/03

180-Day

PROSORBA® Column

Fresenius HemoCare, Inc.

Redmond, WA

98052

Approval for an extension to the PROSORBA® Column’s expiration date from 12 months to 18 months.

P850079/S041

2/12/03

180-Day

Methafilcon A Soft (hydrophilic) Contact Lenses for Extended Wear

CooperVision, Inc.

Norfolk, VA

23507

Approval for an alternate manufacturing facility located at CooperVision, Inc., Norfolk, Virginia.

P900009/S016

2/21/03

Real-Time

Exogen 3000* Low Intensity Fracture Healing System

Smith & Nephew, Inc.

Memphis, TN 38116

Approval for changes to the Exogen 3000* labeling in order that it more closely resemble the approved labeling for the Exogen 2000+*.

P900061/S053

2/21/03

180-Day

GEM model 7227 CX/B/D/E

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a move of the EOC manufacturing operations in Kerkrade, The Netherlands to EOC, Medtronic B.V., Heerlen, The Netherlands.

P900061/S055

2/25/03

Real-Time

Model 2490D E CareLink Monitors and the server-based Model 2491 Device Data Management

Software Application (DDMA)

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Model 2490D/E CareLink Monitors and the server-based Model 2491 Device Data Management Software Application (DDMA) which are indicated for use by the patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection.

P910001/S021

2/4/03

180-Day

Extreme® OTW  0.7 mm X80 Percutaneous Excimer Laser Coronary Angioplasty Catheter, Model 110-005

Spectranetics Corporation

Colorado Springs, CO

80907

Approval for the 0.7 mm size of the Extreme® OTW X80 Percutaneous Excimer Laser Coronary Angioplasty Catheter.

P920047/S018

2/12/03

180-Day

EPT-1000 Cardiac Ablation System

EP Technologies, Inc.

San Jose, CA

95134

Approval for the Blazer RPM catheter which featured minor design changes (e.g., addition of three transducer rings, laser welded center support and multiple coaxial design) to the Blazer II catheter.

P930027/S005

2/28/03

Real-Time

Immulite/

Immulite 1000 PSA assay and Immulite/

Immulite 1000 Third Generation PSA assay

Diagnostic Products Corporation

Los Angeles, CA

90045

Approval for the addition of the Immulite 1000 analyzer to the analyzers used for the Immulite PSA and Immulite Third Generation PSA assays.

P950005/S017

2/4/03

Real-Time

CELSIUS™ and CELSIUS™ II Diagnostic/Ablation Deflectable Tip Catheter

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for establishing and extending package and product shelf lives.

P950037/S031

2/25/03

Real-Time

CardioMessenger (Home Monitoring System)

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Approval for optimized circuitry, upgraded modem, upgraded battery, and aesthetic changes.

P950039/S009

2/5/03

Special

PreservCyt® Solution Alternative Transport Medium

CYTYC Corporation

Boxborough, MA

01719

Approval for the following changes to the package insert:  1) The addition of a contraindication for those samples processed using the ThinPrep 3000 Processing System.  2) The addition of a precaution to address the alternative specimen processing methods using the ThinPrep 2000 Processing System for those samples that will be tested for Chlamydia trachomatis  and Neisseria gonorrhoeae using the Roche Diagnostics COBAS AMPLICOR CT/NG Test.  3) The addition of the alternative specimen handling method to Table 1 of the package insert.

P960013/S011

2/25/03

Real-Time

Tendril SDX Models 1488T/TC/K permanent Pacing Lead

St. Jude Medical, Inc.

Sylmar, CA

91342

Approval for Tendril lead length change.

P960058/S029

2/4/03

180-Day

CLARION® CII Bionic Ear System

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for an optional, adjunct software [Neural Response Imaging (NRI)] to implement a capability to measure and record a neural response using the signal generated and detected by the implant electronics.

P970003/S045

2/28/03

Real-Time

NeuroCybernetic Prosthesis (NCP®) System

Cyberonics, Inc.

Houston, TX

77058

Approval for the following labeling change to the Individualization of Treatment section of the Model 100/101 and 102 Physician’s Manuals  “Preclinical Study, Teratogenic Effects; There are no adequate and well-controlled studies of VNS in pregnant women.  Reproduction studies have been performed using female rabbits stimulated with the commercially available VNS Therapy System at stimulation dose settings similar to those used for humans.  These animal studies have revealed no evidence of impaired fertility or harm to the fetus due to VNS therapy.  Because animal reproduction studies are not always predictive of human response and animal studies cannot address developmental abnormalities, VNS should be used during pregnancy only if clearly needed.  Although the operating ranges of the VNS Therapy System and fetal monitors are dissimilar and no interaction would be expected, testing has not been performed.  Therefore, the potential may exist for interaction between the VNS Therapy System and fetal monitoring systems.”

P970012/S014

2/21/03

180-Day

Kappa 400

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a move of the EOC manufacturing operations in Kerkrade, The Netherlands to EOC, Medtronic B.V., Heerlen, The Netherlands.

P970038/S007

2/28/03

Real-Time

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

Beckman Coulter, Inc.

Chaska, MN

55318

Approval to add the Access Hybritech free PSA

Assay to the UniCel™ DxI 800 Access® Immunoassay System.

P970042/S003

2/14/03

180-Day

Medstone STS-TC/U™ Lithotripter for the Fragmentation of Upper Urinary Tract stones and the Treatment of Symptomatic, Solitary, Radiolucent, Non-Calcified Gallstones

Medstone International, Inc.

Aliso Viejo, CA

92656

Approval for the STS-TC/U Lithotripter (transportable version of the STS Lithotripter with ultrasound).  The device, as modified, will be marketed under the trade name Medstone STS-TC/U Lithotripter and is indicated for  1) the fragmentation of symptomatic upper urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones, and  2) when used in conjunction with certain ursodiols, is indicated for the treatment of symptomatic, solitary, radiolucent, non-calcified gallstones (between 4 and 20 mm in maximum diameter) in adult patients for whom surgical removal of the gallbladder is medically contraindicated and in symptomatic high-risk patients who have actively refused surgery.  Combination therapy consists of

1) administration of Novartis Pharmaceutical Actigall®, or Amide Pharmaceutical Ursodiol, or Teva Pharmaceutical Ursodiol (8-10 mg/kg/day) for at least two weeks pre-lithotripsy,  2) lithotripsy treatments of up to 2000 24 kV shocks, and  3) continued administration of Ursodiol until a stone-free state is achieved.

P980016/S030

2/21/03

180-Day

GEM III DR 7275, GEM III VR 7231, GEM DR 7271

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a move of the EOC manufacturing operations in Kerkrade, The Netherlands to EOC, Medtronic B.V., Heerlen, The Netherlands.

P980016/S033

2/25/03

Real-Time

Model 2490D/E CareLink Monitors and the server-based Model 2491 Device Data Management

Software Application (DDMA)

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Model 2490D/E CareLink Monitors and the server-based Model 2491 Device Data Management Software Application (DDMA) which are indicated for use by the patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection.

P980035/S025

2/21/03

180-Day

Kappa 700/600, 900/800, Sigma/Medtronic 350

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a move of the EOC manufacturing operations in Kerkrade, The Netherlands to EOC, Medtronic B.V., Heerlen, The Netherlands.

P980035/S026

2/25/03

Real-Time

Model 2490D/E CareLink Monitors and the server-based Model 2491 Device Data Management

Software Application (DDMA)

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Model 2490D/E CareLink Monitors and the server-based Model 2491 Device Data Management Software Application (DDMA) which are indicated for use by the patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection.

P980049/S008

2/14/03

180-Day

Swift 1CT Series 4040 Defibrillation Lead (Models 4040, 4041, 4042)

ELA Medical, Inc.

Plymouth, MN

55441

Approval for a defibrillation lead previously approved for manufacture by Angeion under the trade name Angepass.  The lead is now being manufactured by ELA Medical, S.A.  The device, as modified, will be marketed under the trade name Swift 1CT 4040 Series Lead and is indicated for use with an ELA Medical ICD in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: 

1) Survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; 

2) Recurrent, poorly tolerated sustained ventricular tachyarrhythmia.

P980050/S013

2/21/03

180-Day

GEM III AT 7276

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a move of the EOC manufacturing operations in Kerkrade, The Netherlands to EOC, Medtronic B.V., Heerlen, The Netherlands.

P990001/S013

2/21/03

180-Day

DIVA Platform, DERMA Platform

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a move of the EOC manufacturing operations in Kerkrade, The Netherlands to EOC, Medtronic B.V., Heerlen, The Netherlands.

P990025/S008

2/4/03

Real-Time

NAVISTAR™ Diagnostic Ablation Deflectable Tip Catheter

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for establishing and extending package and product shelf lives.

P990027/S004

2/25/03

Panel

TECHNOLAS® 217A Excimer Laser System

Bausch & Lomb Surgical

San Dimas, CA

91773

Approval for the TECHNOLAS 217A Excimer Laser System.  The device uses an optical zone treatment range from 5.00 mm to 6.00 mm with a blend zone of 1.90 mm for spherical hyperopia and 1.75 mm for hyperopic astigmatism.  The laser is locked out for refractive corrections greater than +4.00 D sphere and greater than +2.00 D cylinder.  The device is indicated for laser in-situ keratomileusis (LASIK) treatments:  1) for the reduction or elimination of low-to-moderate naturally occurring hyperopia up to +4.00 diopters (D) MRSE, with sphere between +1.00 to +4,00 D with or without refractive astigmatism up to +2.00 D at the spectacle plane;  2) in patients who are 21 years of age or older; and,  3) in patients with documented evidence of a change in manifest refraction of less than or equal to 0.50 diopters (in both cylinder and sphere components) for at least one year prior to the date of the pre-operative examination.

P990028/S006

2/4/03

Special

FocalSeal-L Synthetic Absorbable Sealant

Genzyme Biosurgery

Cambridge, MA

02139

Approval for revision of storage instructions in the product label.

P990080/S003

2/4/03

Real-Time

Silicone Ultraviolet Light-absorbing Posterior Chamber Intraocular Lenses

Pharmacia & Upjohn Company

Pickerington, OH

43147

Approval for testing ethylene oxide residuals on a quarterly basis.

P000027/S002

2/24/03

180-Day

Elecsys® Free PSA Immunoassay for Elecsys® 1010, 2010, and MODULAR ANALYTICS E170 immunoassay analyzers, Elecsys® Free PSA CalSet and Elecsys® Free PSA CalCheck

Roche Diagnostics Corporation

Indianapolis, IN

46250

Approval for design changes to modify the composition and volumes of the reagents, and labeling changes to add claims for the use of Lithium and NH4-Heparin plasma samples, to eliminate the recommendation for Na Citrate plasma, and to omit the sample dilution claim.  The device, as modified, will be marketed under the trade name Elecsys® Free PSA Immunoassay and is indicated for the in vitro quantitative determination of free prostate-specific antigen in human serum and plasma.  The Elecsys® free PSA immunoassay is indicated for measurement of fPSA in conjunction with the Elecsys® Total PSA assay to develop a ratio (%fPSA) of fPSA to tPSA.  This ratio is useful when used in conjunction with the Elecsys® Total PSA test as an aid in distinguishing prostate cancer from benign prostatic conditions in men age 50 years or older who have a digital rectal examination (DRE) that is not suspicious for prostate cancer and an Elecsys® Total PSA value in the range 4 ng/mL to 10 ng/mL.  Prostate biopsy is required for the diagnosis of prostate cancer.  The electrochemilumi-niscence immunoassay “ECLIA” is intended for use on the Roche Diagnostics Elecsys® 1010 and 2010, and the MODULAR ANALYTICS E170 Immunoassay Analyzers.

P000040/S003

2/20/03

Special

Hydro-ThermAblator® (HTA) Endometrial Ablation System

Boston Scientific Corporation

Natick, MA

07160

Approval for a revised HTA System Installation and Operator’s Manual.

P000049/S006

2/21/03

CardioSeal Septal Occlusion System with Qwik Load

NMT Medical, Inc.

Boston, MA

02210

Approval for an alternate sterilization facility located at Professional Contract Sterilization, Inc, Taunton, Massachusetts.

P000052/S011

2/10/03

180-Day

GALILEO™ III Intravascular Radiotherapy System

Guidant Corporation

Houston, TX

77054

Approval for ceramic glass fiber as an alternate source wire fiber material in the GDT-P32-1 Source Wire, a component of the GALILEO™ III Intravascular Therapy System.

P010007/S001

2/24/03

Real-Time

IMMULITE® AFP and IMMULITE® 2000 AFP

Diagnostics Products Corporation

Los Angeles, CA

90045

Approval for use of the IMMULITE AFP on the IMMULITE 1000 Automated Analyzer.  The device, as modified, will be marketed under the trade name IMMULITE/

IMMULITE 1000 AFP and is indicated:  For in vitro diagnostic use with the IMMULITE and IMMULTE 1000 Analyzers - for the quantitative measurement of alpha-fetoprotein (AFP) in either of two contexts: (a) serial measurements in human serum to aid in the management of patients with nonseminomatous testicular cancer; or (b) measurements in maternal serum and amniotic fluid during gestational weeks 15 through 20 - used in conjunction with ultrasonography or amniography - to aid in detection of fetal open neural tube defects.

P010015/S005

2/25/03

180-Day

InSync III Model 8042 and InSync III Model 9981 Application Software

Medtronic, Inc.

Shoreview, MN

55126

Approval for the InSync III Model 8042 and InSync III Model 9981 Application Software which is indicated as follows:  The InSync III Model 8042 device is indicated for the reduction of symptoms of moderate to severe heart failure (NYHA Class III or IV), in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section), and have a left ventricular ejection fraction ≤35%, and a QRS ≥130 ms.  Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increase in activity.  Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.

P010015/S008

2/21/03

180-Day

INSYNC IPG 8040

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a move of the EOC manufacturing operations in Kerkrade, The Netherlands to EOC, Medtronic B.V., Heerlen, The Netherlands.

P010022/S001

2/4/03

180-Day

CoSeal™ Surgical Sealant (Premixed)

Cohesion Technologies, Inc.

Palo Alto, CA

94303

Approval for: 

1) change in packaging of the polymer resins to a pre-mixed configuration; 

2) change in buffer A to a dilute hydrogen chloride solution with a pH of 2.2;  3) change in sterilization to gamma radiation; and  4) change to room temperature storage.

P010031/S004

2/21/03

180-Day

INSYNC ICD 7272

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a move of the EOC manufacturing operations in Kerkrade, The Netherlands to EOC, Medtronic B.V., Heerlen, The Netherlands.

P010038/S001

2/24/03

180-Day

iCAD

iCAD, Inc.

Tampa, FL

33634

Approval for use of the 3.9.3.7 version of the software.  The new software is intended to improve the overall sensitivity, improve the breast segmentation process, reduce the false marker rate and improve the overall consistency of the algorithm.  The clinical performance claims are not changed.

P010049/S004

2/10/03

Real-Time

QuickSeal II Arterial Closure System

SUB-Q, Inc.

San Clemente, CA

92673

Approval to modify the design of the depth market component and elongate the existing cavity in the tray to accommodate the depth market modification.

P010068/S001

2/4/03

Real-Time

NAVISTAR DS and CELSIUS DS Diagnostic/Ablation Catheters

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for establishing and extending package and product shelf lives.

P020003/S001

2/5/03

180-Day

Mentor Saline-Filled Testicular Prosthesis

Mentor Corporation

Santa Barbara, CA

93111

Approval for revision of the postapproval study protocol to discontinue the requirement for blood collection at the 5-year exam.

P910018/S009

2/14/03

Liposorber® LA-15 System

Kaneka Pharma America Corporation

New York, NY 10036

Change in packaging for the Liposorber® LA-15 System.

P910023/S064

2/12/03

St. Jude Medical Implantable Cardioverter Defibrillators

St. Jude Medical

Sunnyvale, CA

94086

Change in the supplier for the high voltage capacitor cathode material used for the St. Jude Medical implantable cardioverter defibrillators.

P980009/S012

2/26/03

Boston Scientific/Scimed Magic Wallstent® Endoprosthesis with Delivery System

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Change in the manufacturing process to transfer several production steps to an alternate set of production equipment & re-ordering the manufacturing process sequence and eliminating duplicate inspection checks.

P990037/S013

2/21/03

Duett Sealing Devices

Vascular Solutions, Inc.

Minneapolis, MN

55441

Change in the manufacturing procedures to propose reduction in pouch and seal strength tolerance, tolerance change to the knob base and hub base, changes to the sealing and pilot balloons, sleeve marking changes and reduction in the bioburden monitoring limits for the Duett family of sealing devices.

P000014/S005

2/24/03

Vitros Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Change in the acceptance criteria for specific activity applied to the raw material hepatitis B surface antigen sub-type ad from >3.0 x 10⁵ PEI U/mg to ≥2.85 x 10⁵ PEI U/mg.

P000018/S030

2/26/03

Novoste™

Beta-Cath™ System – β-Rail™ 3.5F Delivery Catheter

Novoste Corporation

Norcross, GA

30093

Alternate method of manufacture for the leak testing and drying operation of the β –Rail™ 3.5F Delivery Catheter.

P000020/S008

2/26/03

Bard stinger®, Stinger® S, Stinger® M, and Stinger® SM Ablation Catheters

C.R. Bard, Inc.

Lowell, MA

01851

Change in the packaging for the Bard stinger®, Stinger® S, Stinger® M, and Stinger® SM Ablation Catheters.

P000039/S004

2/21/03

AMPLATZER® Septal Occluder and AMPLATZER®   45 º Delivery and Exchange Systems

AGA Medical Corporation

Golden Valley, MN

55427

Change in the manufacturing process to propose an alternate supplier for the end screw attachment and delivery cable distal end screw of the AMPLATZER® Septal Occluder and AMPLATZER®   45 º Delivery and Exchange Systems.