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Medical Devices
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December 2004 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available. Information about the PDF Reader is available.
PMA Original Approvals
| P010029 12/3/04 |
Nuflexxa (1% Sodium Hyaluronate) | Savient Pharmaceuticals, Inc. East Brunswick, NJ 08816 |
Approval for Nuflexxa (1% Sodium Hyaluronate). The device is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetaminophen). |
| P030022 12/17/04 |
Reflection® Ceramic Acetabular System | Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for the Reflection Ceramic Acetabular System. The device is indicated for use in patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis. |
| P030030 12/16/04 |
URYX® Urethral Bulking Agent | Genyx Medical, Inc. Aliso Viejo, CA 92656 |
Approval for the URYX Urethral Bulking agent (URYX). The device is indicated for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). |
| P030034 12/23/04 |
Cervical-Stim® Model 505L Cervical Fusion System | Orthofix, Inc. McKinney, TX 75069 |
Approval for the Cervical-Stim® Model 505L Cervical Fusion System. The Cervical-Stim® Model 505L Cervical Fusion System is a non-invasive, pulsed electromagnetic bone growth stimulator indicated as an adjunct to cervical fusion surgery in patients at high risk for non-fusion. |
| P030056 12/22/04 |
ADVIA Centaur® HCV Ready Pack Reagents, ADVIA Centaur® HCV Quality Control Materials |
Bayer Healthcare, LLC Tarrytown, NY 10591 |
Approval for the ADVIA Centaur® HCV. HCV ReadyPack Reagents: The ADVIA Centaur® HCV assay is an in vitro diagnostic immunoassay for the qualitative determination of immunoglobulin G (IgG) antibodies to hepatitis C virus (HCV) in human serum and plasma (EDTA, lithium or sodium heparinized) using the ADVIA Centaur® System. The assay may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis C infection. HCV Quality Control Materials: For in vitro diagnostic use in monitoring the performance of the HCV assay on the ADVIA Centaur® Systems. The performance of the HCV quality control material has not been established with any other anti-HCV assays. |
| P040004 12/22/04 |
ADVIA Centaur® HBc Total ReadyPack Reagents, ADVIA Centaur® HBc Total Quality Control Materials |
Bayer Healthcare, LLC Tarrytown, NY 10591 |
Approval for the ADVIA Centaur® HBc Total. HBc Total ReadyPack Reagents: The ADVIA Centaur® HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur® System. This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis B virus (HBV) infection and in the determination of the clinical status of HBV-infected individuals in conjunction with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. HBc Total Quality Control Materials: The controls are indicated for in vitro diagnostic use in monitoring the performance of the HBc Total assay on the ADVIA Centaur® Systems. The performance of the HBc Total Quality Control Material has not been established with any other anti-HBc Total assays. |
| P040018 12/22/04 |
ADVIA Centaur® HAV IgM ReadyPack Reagents, ADVIA Centaur® HAV IgM Quality Control Materials |
Bayer Healthcare, LLC Tarrytown, NY 10591 |
Approval for the ADVIA Centaur® HAV IgM. HAV IgM ReadyPack Reagents: This device is indicated for use for the ADVIA Centaur® HAV IgM assay and is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur System. The assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus. HAV IgM Quality Control Materials: The controls are indicated for in vitro diagnostic use in monitoring the performance of the HAV IgM assay on the ADVIA Centaur® Systems. The performance of the HAV IgM quality control material has not been established with any other anti-HAV IgM assays. |
| P040027 12/6/04 |
GORE VIATORR® TIPS Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 860001 |
Approval for the GORE VIATORR® TIPS Endoprosthesis. The device is indicated for use in de novo and revision treatment of portal hypertension and its complications such as variceal bleeding, gastropathy, ascites, and/or hepatic hydrothorax. |
| P04003012/22/04 | InSite™ Her-2/neu kit | BioGenex Laboratories, Inc. San Ramon, CA 94583 |
Approval for the InSite™ Her-2/neu kit. The device is indicated for: InSite™ Her-2/neu Mouse Monoclonal Antibody (Clone CB11) kit is intended for In Vitro Diagnostic use in Immunohistochem-istry (IHC) assays to semi-quantitatively localized by light microscopy the over-expression of Her-2/neu (i.e., c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue sections. InSite™ Her-2/neu is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® (Trastuzumab) therapy is being considered. Clinical interpretation of InSite™ Her-2/neu immunostaining results (absence or presence; semi-quantitative intensity score) should be complemented by appropriate controls and morphological tissue analysis and be evaluated by a qualified pathologist within the context of patient clinical history and other diagnostic results. |
PMA Supplemental Approvals
| P860057/S024 12/29/04 135-Day |
Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis, Models 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX, 6900P (PERIMOUNT PLUS™), and 6900PTFX | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for an alternative liquid sterilant processing solution. |
| P870056/S017 12/29/04 135-Day |
Carpentier-Edwards® Bioprosthesis, Models 2625 and 6625 and Valved Conduit, Model 4300 | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for an alternative liquid sterilant processing solution. |
| P870077/S015 12/29/04 135-Day |
Carpentier-Edwards® Duraflex® Low Pressure Bioprosthesis, Models 6625LP and 6625-ESR-LP | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for an alternative liquid sterilant processing solution. |
| P890064/S017 12/14/04 Special |
Digene Hybrid Capture® HPV DNA Test | Digene Corporation Gaithersburg, MD 20878 |
Approval for packaging Quality Control material in the Hybrid Capture 2 HPV DNA Test kits that was previously provided under a separate product code, as well as the addition of an upper limit for the HPV positive control test values. |
| P930016S017 12/14/04 Panel |
STAR S4™ Excimer Laser System with Variable Spot Scanning (VSS™) and WaveScan WaveFront® System | VISX, Inc. Santa Clara, CA 95051 |
Approval for the STAR S4™ Excimer Laser System with Variable Spot Scanning (VSS™) and WaveScan WaveFront® System. The device uses a 6.00 mm optical zone, a 9.00 mm treatment zone, and is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): 1) for the reduction or elimination of hyperopia an d hyperopic astigmatism up to 3.00 D MRSE, with cylinder between 0.00 and 2.00 D; 2) in patients 21 years of age or older; and 3) in patients with documented evidence of a change in manifest refraction of no more than 1.0 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination. |
| P950039/S013 12/6/04 180-Day |
ThinPrep 2000 System (includes ThinPrep Pap Test Filters) | Cytyc Corporation Boxborough, MA 01719 |
Approval for a manufacturing site located at Cytyc Corporation, Marlborough, Massachusetts. |
| P970027/S003 12/14/04 Special |
Abbott AxSYN® Anti-HCV | Abbott Laboratories Abbott Park, IL 60064 |
Approval for changes in the manufacturing process. |
| P970029/S009 12/23/04 180-Day |
SolarGen 2100S Laser | CardioGenesis, Inc. Foothill Ranch, CA 92610 |
Approval for the SolarGen 2100S Laser to replace the TMR2000 Laser in the CardioGenesis TMR Holmium Laser System. The SolarGen 2100S will be manufactured by New Star Lasers, Inc. of Roseville, California. |
| P980049/S017 12/8/04 Real-Time |
Elaview 1.26 UG application software for the Orchestra Programmer; RAM Patches Alto P4 and Alto2 P3; and HSO 2.70 Software for the CPR3 Programming Head | ELA Medical, LLC Plymouth, MN 55441 |
Approval for the Elaview 1.26 UG application software for the Orchestra Programmer; RAM Patches Alto P4 and Alto2 P3; and HSO 2.70 Software for the CPR3 Programming Head. |
| P990034/S005 12/23/04 Special |
IsoMed Fixed Rate Infusion Pump | Medtronic Inc. Minneapolis, MN 55432 |
Approval for changes to the IsoMed Fixed Rate Infusion Pump Technical Manual for new warnings and information regarding inflammatory mass and other text changes. |
| P990074/S016 12/17/04 180-Day |
Saline-Filled Breast Implants | Inamed Corporation Santa Barbara, CA 93111 |
Approval for revised labeling that reflects 7-year post-approval study data. |
| P000007/S004 12/29/04 135-Day |
Edwards Prima Plus Stentless Bioprosthesis, Model 2500P | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for an alternative liquid sterilant processing solution. |
| P000021/S004 12/2/04 Real-Time |
Dimension® TPSA Flex® Reagent Cartridge | Dade Behring, Inc. Newark, DE 19714 |
Approval of the Dimension® TPSA Flex Reagent® Cartridge on the Dimension® Xpand Plus™ analyzer. |
| P000058/S005 12/27/04 180-Day |
INFUSE™ Bone Graft/LT-Cage Lumbar Tapered Fusion Device | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for the draft protocol for the rabbit repro/tox study required as a conditions of approval. The proposed study is designed to evaluate the impact of a maternal immune response on the development of offspring. This is determined via an assessment of "...embryo/fetal mortality, fetal weight, and fetal placental morphology..." |
| P010033/S006 12/2/04 180-Day |
QuantiFERON® - TB GOLD | Cellestis, Inc. Valencia, CA 91355 |
Approval for the use of synthetic peptide antigens and removal of two PPD antigens used in the QuantiFERON – TB. The device, as modified, will be marketed under the trade name QuantiFERON – TB Gold and is indicated for use as an in vitro diagnostic test using peptide cocktails simulating ESAT-6 and CFP-10 proteins to stimulate cells in heparinized whole blood. Detection of interferon-y by ELISA is used to identify in vitro responses to ESAT-6 and CFP-10 that are associated with mycobacterium tuberculosis infection. The device approval is for use of an 8-point calibration curve with manual calculations. |
| P010041/S004 12/29/04 135-Day |
Carpentier-Edwards® Supraannular (S.A.V. ®) Bioprosthesis, Model 2650 | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for an alternative liquid sterilant processing solution. |
| P010062/S002 12/3/04 Real-Time |
Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb Vision Shaping Treatment | Bausch & Lomb, Inc. Rochester, NY 14603 |
Approval to revise the Professional Fitting and Information Guide product labeling to include fitting guidelines for corneal topography-based fitting methods and other minor changes and grammatical corrections. The device, as modified, will be marketed under the trade name referenced above with the same prior approved indications for use. |
| P020022/S001 12/14/04 135-Day |
Bayer VERSANT® HCV RNA 3.0 Assay (bDNA) | Bayer HealthCare LLC Berkeley, CA 94702 |
Approval for changes to bulk and raw manufacturing procedures. |
| P030019/S006 12/28/04 180-Day |
ORTHOVISC® Sodium Hyaluronate | Anika Therapeutics, Inc. Woburn, MA 01801 |
Approval to modify the labeling to include safety information concerning a repeat course of treatment of Orthovisc®. |
30-Day Notices (135 Day Supplement was not required)
| P800019/S012 12/22/04 |
Cyberlith® | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P820022/S004 12/22/04 |
Cybertach | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P830026/S079 12/22/04 |
Cosmos | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P830060/S057 12/22/04 |
Ventak, Bipolar Endocardial | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P840068/S043 12/22/04 |
Delta®, Vista® | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P860007/S023 12/22/04 |
Intertach | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P890061/S016 12/22/04 |
Ventak P | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P910020/S026 12/22/04 |
Relay | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P910073/S049 12/22/04 |
Endotak®, Endotak Endurance, Endotak Reliance® |
Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P910077/S049 12/22/04 |
Ventak PRx, Ventak Mini | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P930035/S014 12/22/04 |
Ventak P2, Ventak P3 | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P940008/S020 12/22/04 |
Res-Q | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P940031/S033 12/22/04 |
Vigor®, Discovery®, Meridian® | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P950001/S013 12/22/04 |
Selute, Selute Picotip | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P960004/S027 12/22/04 |
Fineline®, Fineline® II | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P960006/S013 12/22/04 |
Sweet Tip Rx, Sweet Picotip Rx, Flextend® | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P960040/S050 12/22/04 |
Ventak AV, Ventak VR, Ventak Prizm®, Vitality®, Vitality® 2 | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| D970003/S031 12/22/04 |
Pulsar®, Pulsar® Max Insignia® | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P970027/S002 12/3/04 |
AxSYM Anti-HCV | Abbott Laboratories Abbott Park, IL 60064 |
Change to the acceptance criteria for microparticle manufacturing. |
| P980035/S040 12/20/04 |
Kappa 700, Kappa 900, EnPulse | Medtronic, Inc Minneapolis, MN 55432 |
Reduction of hybrid burn-in time for several Medtronic products. |
| P980046/S007 12/10/04 |
Hepatitis C Check Test System | Home Access Health Corporation Hoffman Estates, IL 60195 |
Change to a supplier of a component of the Hepatitis C Check Test System. |
| P000044/S005 12/8/04 |
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator, and the VITROS Immunodiagnostic Products HBsAg Confirmatory Kit | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Change in the manufacturing equipment and manufacturing process steps acceptance criteria associated with this equipment change. |
| P010012/S038 12/15/04 |
CONTAK RENEWAL 1 Cardiac Resynchronization Therapy Defibrillator | Guidant Corporation St. Paul, MN 55112 |
Addition of an adhesive, a new manufacturing step, and pre-forming of a wire. |
| P010012/S040 12/22/04 |
Contak CD, Contak CD2, Easytrak®, Easytrak® 2, Easytrak® 3, Contak Renewal®, Contak Renewal® 3 | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P020004/S008 12/2/04 |
Gore Excluder® Bifurcated Endoprosthesis | W.L. Gore and Associates Flagstaff, AZ 86002 |
Change involving a new specification for the Trunk-Ipsilateral Leg Endoprosthesis (Trunk) seamline inspection. |
| P030005/S006 12/22/04 |
Contak Renewal® TR | Guidant Corporation St. Paul, MN 55112 |
Use of a new biological indicator for the sterilization process. |
| P040027/S001 12/29/04 |
GORE VIATORR® TIPS Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Removal of a manufacturing aid and some processing steps. |
Summary of PMA Originals & Supplements Approved
Originals: 9
Supplements: 19
Summary of PMA Originals Under Review
Total Under Review: 78
Total Active: 33
Total On Hold: 45
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 244
Total Active: 136
Total On Hold: 108
Number Greater Than 180 Days: 5
Summary of All PMA Submissions Received
Originals: 7
Supplements: 70
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 19
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 132.2
FDA Time: 101 Days MFR Time: 31.2 Days
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