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PMA Final Decisions Rendered for February 2003 |
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
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). |
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. |
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
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. |
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. |
30-Day Notices (135 Day Supplement was not required)
APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
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. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 42
Summary of PMA Originals Under Review
Total Under Review: 67
Total Active: 30
Total On Hold: 37
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 257
Total Active: 147
Total On Hold: 110
Number Greater Than 180 Days: 1
Summary of All PMA Submissions Received
Originals: 0
Supplements: 52
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 42
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 102.7
FDA Time: 76 Days MFR Time: 26.7 Days
Updated 3/14/2003
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