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PMA Final Decisions Rendered for May 2004 |
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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.
APPLICATION NUMBER / DATE OF APPROVAL | DEVICE TRADE NAME | COMPANY NAME, CITY, STATE AND ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
5/14/04 |
ADVIA Centaur® Anti-HBs ReadyPack Reagents, ADVIA Centaur® Anti-HBs ReadyPack Calibrators |
Bayer HealthCare LLC Tarrytown, NY 10591 |
Approval for the ADVIA Centaur Anti-HBs ReadyPack Reagents and ADVIA Centaur Anti-HBs ReadyPack Calibrators. The device is indicated for the qualitative determination of total antibodies to hepatitis B surface antigen in human serum or plasma (EDTA or heparinized) using the ADVIA Centaur System. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in 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 in unknown. |
5/13/04 |
St. Jude Frontier™ Biventricular Cardiac Pacing System including the Frontier™ Model 5508 and 5508L Pulse Generators, the Aescula™ LV Model 1055K Lead and the Model 3307 v4.4.2m programmer software for use with the Model 3500/3510 Programmer |
St. Jude Medical Sylmar, CA 91342 |
Approval for the St. Jude Frontier Biventricular Cardiac Pacing System. The Frontier Biventricular Pacing System is indicated for maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. |
APPLICATION NUMBER / DATE OF APPROVAL | DEVICE TRADE NAME | COMPANY NAME, CITY, STATE AND ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P800022/S052 5/11/04 180-Day |
CosmoDerm and CosmoPlast Human-Based Collagen |
Inamed Corporation Santa Barbara, CA 93111 |
Approval for a new raw material supplier for the human collagen component of CosmoDerm and CosmoPlast (i.e., Immucor/Gamma Biologicals of Houston, Texas). |
P8400039/S054 5/27/04 180-Day |
OcuCoat, PMMA and Silicone Intraocular Lenses |
Bausch & Lomb, Inc. Sam Dimas, CA 91773 |
Approval for a sterilization site located at CosMed, Inc., Plainfield, New Jersey. |
P860040/S016 5/28/04 180-Day |
BioCurve Soft Contact Lenses |
Cal Bionics, Inc. Novato, CA 94947 |
Approval to relocate some manufacturing processes to the site located at American BioCurve, Inc., San Diego, California. |
P860047/S018 5/27/04 180-Day |
OcuCoat, PMMA and Silicone Intraocular Lenses |
Bausch & Lomb, Inc. Sam Dimas, CA 91773 |
Approval for a sterilization site located at CosMed, Inc., Plainfield, New Jersey. |
P880090/S021 5/27/04 180-Day |
OcuCoat, PMMA and Silicone Intraocular Lenses |
Bausch & Lomb, Inc. Sam Dimas, CA 91773 |
Approval for a sterilization site located at CosMed, Inc., Plainfield, New Jersey. |
P890064/S014 5/4/04 180-Day |
Digene Hybrid Capture® 2 High-Risk HPV DNA Test |
Digene Corporation Gaithersburg, MD 20878 |
Approval to include the optional use of an automated, high-throughput robotic pipetting and microplate handling system known as the Digene Rapid Capture System (RCS). |
P900009/S019 5/7/04 Real-Time |
Exogen 2000+ |
Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for the addition of 2 diodes in series with the positive lead of the 5-cell battery pack on the Exogen 2000+ Low Intensity Ultrasound Fracture Healing System. |
P910023/S073 5/12/04 Real-Time |
Housecall Plus™ Transtelephonic Monitoring System with Model 3180-T Transmitter and Model 3180-R Receiver Software (Version 2.0) |
St. Jude Medical Sunnyvale, CA 94086 |
Approval for software modifications to the St. Jude Medical Housecall Plus™ Receiver software (version 2.0) which also includes the support for the St. Jude Medical Epic and Atlas ICD families. |
P910061/S012 5/27/04 180-Day |
OcuCoat, PMMA and Silicone Intraocular Lenses |
Bausch & Lomb, Inc. Sam Dimas, CA 91773 |
Approval for a sterilization site located at CosMed, Inc., Plainfield, New Jersey. |
P910065/S005 5/25/04 180-Day |
ST AIA-PACK PA |
TOSOH Bioscience, Inc. S. San Francisco, CA 94080 |
Approval of the TOSOH ST AIA-PACK PA assay to be used on the TOSOH AIA-360 and TOSOH AIA-1800 Automated Immunoassay Systems, members of the TOSOH AIA Automated Immunoassay System family. The device, as modified, will be marketed under the same trade name ST AIA-PACK PA and is indicated for: ST AIA-PACK PA is designed for in vitro diagnostic use only for the quantitative measurement of Prostate Specific Antigen (PSA) in human serum on TOSOH AIA Nex*IA, AIA-600 II, AIA-1800 and AIA-360 analyzers. This 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 (CaP) in men fifty years of age and older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA in human serum to be used as an aid in the management of patients with prostatic cancer. |
P920047/S023 5/18/04 Real-Time |
Blazer RPM Cardiac Ablation Catheter |
Boston Scientific Corporation San Jose, CA 95134 |
Approval for a change in the expiration date from one-year to three-years. |
P960040/S043 5/4/04 Real-Time |
VITALITY® 2 System Guide |
Guidant Corporation St. Paul, MN 55112 |
Approval for minor updates to the VITALITY® 2 System Guide Clinical Section. |
D970012/S021 5/7/04 Real-Time |
AMS 700 Series Product Line Inflatable Penile Prostheses |
American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for the addition of 4 cm, 5 cm and 6 cm rear tip extenders (RTEs) for the AMS 700 CXT cylinders. |
P970018/S007 5/28/04 |
PrepStain™ System |
TriPath Imaging Redmond, WA 98052 |
Approval for modified labeling of the PrepStain System for use with an alternate specimen collection device. |
P970051/S027 5/18/04 Real-Time |
Nucleus 24 Cochlear Implant System with Nucleus 24 Contour Advance/Softip II Electrode and Insertion Tool |
Cochlear Americas Englewood, CO 80112 |
Approval for an electrode insertion tool to facilitate placement of the electrode into the cochlea as well as minor modifications to the Softip electrode to optimize its interaction with the insertion tool. The device, as modified, will be marketed under the trade name Insertion Tool for the Nucleus 24 Contour Advance/Softip Electrode II. |
P970053/S008 5/28/04 Real-Time |
Nidek EC-5000 Excimer Laser System |
Nidek, Inc. Freemont, CA 94539 |
Approval to replace the 60Hz eyetracker with the 200 Hz eyetracker in the Nidek EC-5000 Excimer Laser System for the treatment of myopia and myopic astigmatism. |
P980007/S004 5/7/04 Real-Time |
Abbott ARCHITECT Free PSA |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for addition of the Architect Free PSA to the i2000sr Platform, a member of the ARCHITECT® i2000 instrument family. The device, as modified, will be marketed under the trade name Architect Free PSA and is indicated for the quantitative determination of free prostate specific antigen (PSA) in human serum. The Architect Free PSA is intended to be used in conjunction with the Architect Total PSA assay in men aged 50 years or older with total PSA values between 4 and 10 ng/mL and DRE non-suspicious for cancer to determine the % free PSA value. The Architect % free PSA value can be used as an aid in discriminating between prostate cancer and benign disease. |
P980037/S007 5/5/04 180-Day |
Possis AngioJet® Rheolytic™ Thrombectomy System |
Possis Medical, Inc. Minneapolis, MN 55433 |
Approval for the XMI® Rapid Exchange (XMI-RX) Catheter, a modification of the XMI-OTW Catheter. The device, as modified, will be marketed under the trade name Possis AngioJet® XMI® Rapid Exchange Rheolytic™ Thrombectomy System, and is indicated for removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels >=2.0 mm in diameter prior to balloon angioplasty or stent placement. |
P980049/S015 5/4/04 Real-Time |
Elaview 1.22 UG application software |
ELA Medical, LLC Plymouth, MN 55441 |
Approval for two addition features (Telassistance and Clinical Registry) to the Elaview 1.22 UG application software. |
P990023/S003 5/26/04 Special |
Cellugel Ophthalmic Viscosurgical Device |
Alcon Laboratories Fort Worth, TX 76134 |
Approval to add syringe assembly illustrations and instructions to the labeling. |
P000025/S012 5/14/04 180-Day |
MED-EL COMBI 40+ Cochlear Implant System with MED-EL CI.STUDIO+ release version 2.0 Software |
MED-EL Corporation Durham, NC 27713 |
Approval for MED-EL CI.STUDIO+ release version 2.0 Software for the MED-EL COMBI 40+ Cochlear Implant System. |
P000049/S012 5/10/04 Special |
CardioSEAL® Septal Occlusion System with QwikLoad™ |
Nitinol Medical Technologies, Inc. Boston, MA 02210 |
Approval for the addition of a warning to the labeling that protamine sulfate should not be used for heparin reversal because of the potential for thrombus formation. |
P000052/S024 5/4/04 Special |
GALILEO® Intravascular Radiotherapy System |
Guidant Corporation Houston, TX 77054 |
Approval for the addition of a secondary wipe station to the manufacturing process for the GDT-P32-1 Source Wires. |
P000053/S004 5/7/04 Real-Time |
AMS Sphincter 800™ Urinary Prosthesis |
American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for a new manufacturing procedure to produce the cuff backing, a design change to the thickness of the cuff backing, a material change in the silicone, and a promotional claim regarding the cuff wear characteristics of the modified design. |
P010003/S003 5/3/04 Real-Time |
BioGlue Surgical Adhesive in syringe delivery system (Model BG3500) |
CryoLife, Inc. Kennesaw, GA 30144 |
Approval for a disposable dual-barrel piston-driven syringe dispensing system as an alternate to the current dual-barrel reusable ratcheting piston-driven cartridge system. The device, as modified, will be marketed under the trade name BG3500 and is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral, and carotid arteries). |
P010017/S004 5/12/04 180-Day |
SenoScan Full Field Digital Mammography System |
Fisher Imaging Corporation Denver, CO 80241 |
Approval for changes in the x-ray filter, skin line algorithm, Operator’s Manual and QC Manual changes under MQSA. |
P010030/S005 5/3/04 Real-Time |
LifeVest WCD 3000S |
Lifecor, Inc. Pittsburg, PA 15321 |
Approval for modifications to the LifeVest WCD 3000 device to better facilitate short-term use. The device, as modified, will be marketed under the trade name LifeVest WCD 3000S and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. The LifeVest WCD 3000S system is intended for short-term use in a medically supervised environment. The device is not intended to be worn home. |
P010031/S012 5/28/04 180-Day |
Medtronic InSync ICD Model 7272 and Model 9969 Application Software |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for 1) changes to the investigational plan and implant forms of the post-approval study and 2) the addition of the InSync Model 7277 with Model 9983 Application Software to the study. |
P010032/S011 5/5/04 180-Day |
Genesis Neurostimulation (IPG) System |
Advanced Neuromodulation Systems, Inc. Plano, TX 75024 |
Approval for a manufacturing site located at Advanced Neuromodulation Systems, Inc., Plano, Texas. |
P010038/S006 5/21/04 180-Day |
iCAD System |
iCAD, Inc. Beavercreek, OH 45431 |
Approval for a manufacturing site located at ScanOptics, Inc, Manchester, Connecticut. |
P010038/S007 5/19/04 Real-Time |
iCAD System |
iCAD, Inc. Beavercreek, OH 45431 |
Approval for replacing the iCAD System’s CAD software with the Second Look CAD software and increasing the system memory from 1 Gigabyte to 2 Gigabytes. The device, as modified, will be marketed under the trade name Second Look 200 and is indicated for: Second Look is a computed system intended to identify and mark regions of interest on standard mammographic views, including views from patients with breast implants and images from qualified Full Field Digital Mammography systems, to bring 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. |
P010043/S001 5/26/04 180-Day |
Lea’s Shield Barrier Contraceptive |
Yama, Inc. Union, NJ 07083 |
Approval for a manufacturing site located at Yama, Inc., Union, New Jersey. |
P010049/S010 5/25/04 180-Day |
QUICKSEAL SURESHOT Arterial Closure System |
Sub-Q, Inc. San Clemente, CA 92673 |
Approval to modify the design of the QuickSeal Arterial Closure System to allow the delivery of Q-Foam hemostatic sponge through an introducer delivery sheath and eliminate the depth market component. The device, as modified, will be marketed under the trade name QuickSeal SureShot and is indicated for use in reducing time to hemostatis at femoral artery puncture sites and in reducing time to ambulation in patients who have undergone diagnostic or interventional procedures using 8 French or smaller procedural sheaths. The device reduces time to eligibility for hospital discharge in patients who have undergone diagnostic or interventional procedures and reduces time to actual hospital discharge in patients who have undergone diagnostic procedures. |
P020006/S004 5/26/04 180-Day |
Enteryx Procedure Kit |
Boston Scientific Corporation Natick, MA 01760 |
Approval for a manufacturing site located at Life Science Outsourcing, Brea, California. Final assembly of the Enteryx injector and the kitting procedures will be performed at this facility. |
P020009/S015 5/5/04 Special |
Express2 Monorail and Over-the-Wire Coronary Stent Systems |
Boston Scientific Corporation Natick, MA 01760 |
Approval to implement the following: 1) The addition of an additional in-process inspection, 2) Modification of a current in-process inspection, and 3) Modification of a manufacturing process to address complaints related to failure of the delivery system balloon to properly deflate following stent deployment. |
P020045/S004 5/3/04 Real-Time |
Freezor Cardiac Cryoablation Catheter |
CryoCath Technologies, Inc. Quebec, Canada H9H 5H3 |
Approval for modifications made to the Freezor Cardiac Cryoablation catheter approved under P020045. |
P030025/S002 5/5/04 Special |
TAXUS Express2™ Monorail™ and Over-the-Wire Coronary Stent Systems |
Boston Scientific Corporation Natick, MA 01760 |
Approval to implement the following: 1) The addition of an additional in-process inspection, 2) Modification of a current in-process inspection, and 3) Modification of a manufacturing process to address complaints related to failure of the delivery system balloon to properly deflate following stent deployment. |
APPLICATION NUMBER / DATE OF APPROVAL | DEVICE TRADE NAME | COMPANY NAME, CITY, STATE AND ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P830060/S054 5/14/04 |
VENTAK®, Bipolar Endocardial Leads |
Guidant Corporation St. Paul, MN 55112 |
Change in the aeration time used by Guidant’s alternate sterilization site. |
P890061/S014 5/14/04 |
VENTAK P |
Guidant Corporation St. Paul, MN 55112 |
Change in the aeration time used by Guidant’s alternate sterilization site. |
P910073/S045 5/14/04 |
ENDOTAK®, ENDOTAK ENDURANCE, ENDOTAK RELIANCE |
Guidant Corporation St. Paul, MN 55112 |
Change in the aeration time used by Guidant’s alternate sterilization site. |
P910077/S045 5/14/04 |
VENTAK PRx, VENTAK MINI® |
Guidant Corporation St. Paul, MN 55112 |
Change in the aeration time used by Guidant’s alternate sterilization site. |
P930031/S021 5/7/04 |
Wallstent (TIPS and Venous) Endoprosthesis with Unistep Plus Delivery System |
Boston Scientific Natick, MA 01760 |
Change in the manufacturing material used in the manufacture of the exterior tube for the device. |
P930035/S012 5/14/04 |
VENTAK P2, VENTAK P3 |
Guidant Corporation St. Paul, MN 55112 |
Change in the aeration time used by Guidant’s alternate sterilization site. |
P940031/S031 5/14/04 |
VIGOR®, DISCOVERY®, MERIDIAN® |
Guidant Corporation St. Paul, MN 55112 |
Change in the aeration time used by Guidant’s alternate sterilization site. |
P950001/S011 5/14/04 |
SELUTE®, SELUTE PICOTIP |
Guidant Corporation St. Paul, MN 55112 |
Change in the aeration time used by Guidant’s alternate sterilization site. |
P960004/S025 5/14/04 |
FINELINE®, FINELINE II |
Guidant Corporation St. Paul, MN 55112 |
Change in the aeration time used by Guidant’s alternate sterilization site. |
P960006/S010 5/14/04 |
SWEET TIP® Rx, SWEET PICOTIP® Rx, FLEXTEND® |
Guidant Corporation St. Paul, MN 55112 |
Change in the aeration time used by Guidant’s alternate sterilization site. |
P960040/S044 5/14/04 |
VENTAK AV, VENTAK VR, VENTAK PRIZM™, VITALITY®, VITALITY 2 |
Guidant Corporation St. Paul, MN 55112 |
Change in the aeration time used by Guidant’s alternate sterilization site. |
P960058/S035 5/14/04 |
Hiresolution and Clarion CII Bionic Ear Systems |
Advanced Bionics Corporation Sylmar, CA 91342 |
Expansion of sterilization capacity using an alternate sterilization chamber. |
D970003/S028 5/14/04 |
PULSAR®, PULSAR MAX, INSIGNIA® |
Guidant Corporation St. Paul, MN 55112 |
Change in the aeration time used by Guidant’s alternate sterilization site. |
P970004/S028 5/27/04 |
Medtronic Interstim Therapy for Urinary Control, Lead Models 3080, 3886, 3889, 3092, 3093, 3966, and 3095 |
Medtronic Gastroenterology and Urology Shoreview, MN 55126 |
Change in the supplier of raw materials used to manufacture the products. |
P980033/S010 5/7/04 |
Wallstent (TIPS and Venous) Endoprosthesis with Unistep Plus Delivery System |
Boston Scientific Natick, MA 01760 |
Change in the manufacturing material used in the manufacture of the exterior tube for the device. |
P980044/S001 5/27/04 |
Supartz® |
Smith & Nephew, Inc. Memphis, TN 38116 |
Change in the carton packaging process for Supartz® from manual to automated. |
P990038/S006 5/3/04 |
DiaSorin ETI-MAK-2-PLUS |
DiaSorin S.p.A. Stillwater, MN 55082 |
Change in the quality control tests used to determine specific attributes of incoming materials. |
P990038/S008 5/19/04 |
DiaSorin ETI-MAK-2 PLUS |
DiaSorin S.p.A. Stillwater, MN 55082 |
Change in the manufacturing materials used to produce the ETI-MAK-2 PLUS Tracer Diluent. This change was to add inactivated horseradish peroxidase, 2.5 mg/L, to the ETI-MAK-2 PLUS Tracer Diluent. |
P000010/S003 5/6/04 |
AMPLICOR® HCV Test v2.0 |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Incorporation of a terminal 0.2 µm filtration step to the Avidin-Horseradish Peroxidase (HRP) BGG Conjugate reagent manufacturing process. The submission identified the change for which the approval is being requested and provides the rationale for the change. |
P000014/S007 5/14/04 |
VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators |
Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Replacement of key equipment used in performing the Coated Well test Procedure and the acceptance criteria associated with its use. In addition, the coated well sampling plan, randomization methods for sampling, and test error correction methods have been improved to further ensure batch quality and reduce production waste. The Coated Well Test Procedure is used to verify an acceptable level of well-to-well precision and outlier-level incidence in the coated wells manufactured for the VITROS Anti-HBs Assay. |
P000049/S013 5/14/04 |
CardioSEAL® Septal Occlusion System with QwikLoad |
NMT Medical, Inc. Boston, MA 02210 |
Change in the manufacturing process to propose an alternate vendor for the device. |
P000049/S014 5/21/04 |
CardioSEAL® Septal Occlusion System with QwikLoad |
NMT Medical, Inc. Boston, MA 02210 |
Changes related to the implant fabric. The proposed changes involve transferring the fabric heat set and fabric cut steps to an alternate vendor. |
P010012/S027 5/14/04 |
CONTAK CD®, CONTAK CD 2, EASYTRAK®, CONTAK RENEWAL®, CONTAK RENEWAL 3 |
Guidant Corporation St. Paul, MN 55112 |
Change in the aeration time used by Guidant’s alternate sterilization site. |
P020009/S016 5/14/04 |
Express 2 Coronary Stent System |
Boston Scientific Maple Grove, MN 55311 |
Reduction in the sampling plan for destructive balloon burst testing. |
P020023/S004 5/5/04 |
Restylane Injectable Gel |
Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Addition of a 1 ml vial size for the Restylane Injectable Gel. |
P020023/S005 5/10/04 |
Restylane Injectable Gel |
Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Three changes in the manufacturing processes. |
P020023/S006 5/10/04 |
Restylane Injectable Gel |
Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Changes in increasing utilization for some of the manufacturing process equipment. |
P030025/S003 5/14/04 |
Taxus Express 2 Coronary Stent System |
Boston Scientific Maple Grove, MN 55311 |
Reduction in the sampling plan for destructive balloon burst testing. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 36
Summary of PMA Originals Under Review
Total Under Review: 89
Total Active: 42
Total On Hold: 47
Number Greater Than 180 Days: 2
Summary of PMA Supplements Under Review
Total Under Review: 208
Total Active: 120
Total On Hold: 88
Number Greater Than 180 Days: 4
Summary of All PMA Submissions Received
Originals: 3
Supplements: 51
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 36
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 88.6
FDA Time: 65.3 Days MFR Time: 23.3 Days
Updated October 28, 2004
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