August 2004 PMA Approvals

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for August 2004. 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

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P020055 8/11/04	Ventana® Medical Systems PATHWAY Anti-c-KIT (9.7) Primary Antibody	Ventana Medical Systems, Inc. Tucson, AZ 85737	Approval for the Ventana ® Medical Systems PATHWAY Anti-c-KIT (9.7) Primary Antibody. The device is indicated as follows: Ventana ® Medical Systems’ PATHWAY Anti-c-KIT (9.7) Primary Antibody is intended for laboratory use, via light microscopy, for the qualitative detection of KIT protein in formalin-fixed, paraffin-embedded gastrointestinal stromal tumors (GISTs) using either an automated immunohistochem-istry staining system or a manual assay. It is indicated as an aid in the diagnosis of GIST within the context of the patient’s clinical history, tumor morphology, and other diagnostic tests evaluated by a qualified pathologist. It may be used after the diagnosis of GIST as an aid in the selection of GIST patients who may qualify for imatinib mesylate (Gleevec ®) therapy. PATHWAY Anti-c-KIT (9.7) Primary Antibody is optimized for use on Ventana Automated Slide Stainer and for manual application in combination with Ventana Medical Systems’ iVIEW™ DAB Detection Kit and accessories. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests.
P030010 8/20/04	Siemens Mammomat Novationdr Full Field Digital Mammography System	Siemens Medical Solutions USA, Inc. Malvern, PA 19355	Approval for the Siemens Mammomat Novationdr Full Field Digital Mammography System. The device generates digital mammographic images that can be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional film-based mammographic systems. These mammographic images can be interpreted by either hardcopy film or by softcopy at a workstation.
P030040 8/6/04	ADVIA Centaur® HBc IgM ReadyPack Reagents, ADVIA Centaur® HBc IgM Quality Control Materials.	Bayer Healthcare, LLC Tarrytown, NY 10591	Approval for the ADVIA Centaur HBC IgM. HBc IgM Ready Pack Reagents: This device is indicated for use for the ADVIA Centaur® HBc IgM assay and is an in vitro diagnostic test for the qualitative determination if IgM response to hepatitis B virus core antigen in human serum and plasma (EDTA or lithium or sodium heparinized) using the ADVIA Centaur ® System. The assay uses recombinant HBc antigen. This assay may be used in combination with other hepatitis B virus (HBV) market assays to define the clinical status of known HBV infected patients or can be combined with other HBV, HAV (hepatitis A virus), and HCV (hepatitis C virus) assays for the diagnosis of patients presenting symptoms of acute viral hepatitis. Assay performance characteristics have not been established for immunocompro-mised or immunosuppressed patients, cord blood, neonatal specimens, infants or children. Assay performance characteristics have not been established when the ADVIA Centaur HBc IgM assay is used in conjunction with other manufacturers’ assays for specific HBV serological markers. HBc IgM Quality Control Materials: The controls are indicated for in vitro diagnostic use in monitoring the performance of the HBc IgM assay on the ADVIUA Centaur ® Systems. The performance of the HBc IgM quality control material has not been established with any other anti-HBc IgM assays.
P030050 8/3/04	Sculptra	Aventis Pharmaceuticals, Inc. Berwyn, PA 19312	Approval for Sculptra. The device is intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
P040012 8/30/04	ACCULINK™ Carotid Stent System and RX ACCULINK™ Carotid Stent System	Guidant Corporation Santa Clara, CA 95054	Approval for the ACCULINK™ Carotid Stent System and RX ACCULINK™ Carotid Stent System. The ACCULINK™ Carotid Stent System and the RX ACCULINK™ Carotid Stent System, used in conjunction with Guidant carotid embolic protection systems, are indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. 1) Patients with neurological symptoms and 50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and 80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND 2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P840002/S012 8/27/04 Real-Time	External Pulse Generator Model 2A, Tapscope 500 Series Esophageal Stethoscope and Pacing Catheter, Tapscope 210 Esophageal Pacing Catheter, Tapscope 210S Esophageal Pacing Catheter	CardioCommand, Inc. Tampa, FL 33607	Approval for the interchangeability of existing approved products. Those products are external pulse generators (Models 2A, 7A, and 7B) and Esophageal Catheter Systems (Models 205, 210, 210S, 1600, 500 Series, and Tapsul.)
P860008/S018 8/27/04 Real-Time	External Pulse Generator Models 7A and 7B, Tapcath 205 Esophageal Pacing Catheter, Tapsul 200 Esophageal Pacing Gelatin Capsul, Octopolar 1600 Esophageal Pacing Catheter	CardioCommand, Inc. Tampa, FL 33607	Approval for the interchangeability of existing approved products. Those products are external pulse generators (Models 2A, 7A, and 7B) and Esophageal Catheter Systems (Models 205, 210, 210S, 1600, 500 Series, and Tapsul.)
P870072/S027 8/3/04 180-Day	Thoratec ® Implantable Ventricular Assist Device (IVAD)	Thoratec Corporation Pleasanton, CA 94588	Approval for the Thoratec Implantable Ventricular Assist Device (IVAD) as an alternate VAD blood pump for use in the approved Thoratec Ventricular Assist Device System. The device, as modified, will be marketed under the trade name Thoratec Implantable Ventricular Assist Device and is indicated for use in bridge to transplant patients who meet all of the following criteria: candidate for cardiac transplantation, imminent risk of dying before donor heart procurement, dependence on, or incomplete response to, continued vasopressor support. It is also indicated for postcardiotomy recovery patients who are unable to be weaned from cardiopulmonary bypass. In addition, the IVAD is designed to be compatible with both the Dual Driver Console and TLC-II Portable VAD Driver.
P870072/S028 8/3/04 Real-Time	Thoratec® Paracorporeal ventricular Assist Device (PVAD) System and TLC-ii Portable VAD Driver	Thoratec Corporation Pleasanton, CA 94588	Approval for a modification to the circuitry associated with the battery supervisor chip used in the battery packs that provide power for the TLC-II portable pneumatic driver.
P890023/S15 8/2/04 180-Day	Hydrogenics ® 60 (Ocufilcon F) UV IMT Soft (Hydrophilic) Contact Lens for Extended Wear	Ocular Science Eastleigh, Hampshire, United Kingdom S053 4ND	Approval for an alternate manufacturing site located at Ocular Sciences, Inc., Albuquerque New Mexico.
P890055/S017 8/18/04 180-Day	Codman Model 3000 Series Constant Flow Implantable Pump	Codman & Shurtleff, Inc. Raynham, MA 02767	Approval for a manufacturing site located at Codman & Shurtleff, Inc., Raynham, Massachusetts.
P960016/S010 8/20/04 180-Day	Livewire TC™ Cardiac Ablation System: Extension Cables Models 402506 and 402518	St. Jude Medical Minnetonka, MN 55345	Approval for a labeling change indicating that the cables can be cleaned and resterilized up to ten (10) times in a STERRAD® 100s Gas Plasma Sterilizer.
P960016/S011 8/4/04 135-Day	Livewire TC™ Cardiac Ablation System	St. Jude Medical Minnetonka, MN 55345	Approval for modifying the manufacturing cleaning solvent; and cleaning and resterilization of the cables up to ten (10) times in either a STERRAD 100S Gas Plasma Sterilizer or up to ten (10) times with EtO gas sterilizer using the cycle parameters specified in the instructions for use.
P960043/S055 8/30/04 Special	Perclose® ProGlide™ 6 Fr. Suture-Mediated Closure (SMC) System	Abbott Vascular Devices Redwood City, CA 94063	Approval for revised instructions for use intended to enhance the safe use of the devices.
P960058/S036 8/4/04 180-Day	HiResolution™ Bionic Ear System	Advanced Bionics Corporation Sylmar, CA 91342	Approval for labeling changes to indicate that the HiResolution Bionic Ear System is safe for MRI at levels of 0.3 Tesla/12 MHz and 1.5 Tesla/64 MHz.
P960058/S038 8/24/04 180-Day	HiResolution™ Bionic Ear System	Advanced Bionics Corporation Sylmar, CA 91342	Approval for an interim design change for the Auria PowerPak accessory to the HiResolution™ Bionic Ear System. Specifically, you propose the addition of an insulating washer to the Auria PowerPak assembly while you develop a final design solution for the recently discovered safety issue associated with this device. We note that you agree to design, test, manufacture, and distribute the revised Auria PowerPak model with the final design solution within six months of the date of this letter. We further note that you agree to submit a supplement to FDA for the proposed final design once the design and test activities have been complete and will not distribute the revised Auria PowerPak without FDA approval.
P970021/S011 8/23/04 Real-Time	Gynecare THERMACHOICE III Uterine Balloon Therapy System	Gynecare Somerville, NJ 08876	Approval for labeling changes for the THERMACHOICE III.
P980016/S043 8/18/04 Real-Time	Medtronic Intrinsic Models 7287 and 7288 ICD Systems	Medtronic, Inc. Minneapolis, MN 55432	Approval for a RAMware update to the Medtronic Intrinsic Models 7287 and 7288 ICD Systems.
P980016/S044 8/25/04 Real-Time	Maximo VR Models 7232B and 7232E Implantable Cardioverter Defibrillators	Medtronic, Inc. Minneapolis, MN 55432	Approval for the addition of B and E connectors to the Maximo VR Model 7232.
P980035/S034 8/25/04 180-Day	EnPulse Implantable Pulse Generator and Model 9991 Application Software	Medtronic, Inc. Minneapolis, MN 55432	Approval for a manufacturing site located at Medtronic Puerto Rico Operations Company, Juncos, Puerto Rico.
P980041/S006 8/4/04 Real-Time	Access® AFP Reagents on the Access Immunoassay Analyzer	Beckman Coulter, Inc. Chaska, MN 55318	Approval of the addition of an assay protocol file to the assay software of the Access ® AFP Reagent for on-board system auto-dilution of human serum and amniotic fluid samples for all Access ® Immunoassay Anlayzers (Access ®, Access ® 2, SYNCHRON ® LXi 725 and UniCel ® DxI 800). The Access ® AFP assay is a paramagnetic particle, chemiluminescent immunoassay for the use with the Access ® Immunoassay Systems for the quantitative determination of alpha-fetoprotein (AFP) in: 1) Human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2) Maternal serum and amniotic fluid at 15 to20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.
P990086/S004 8/6/04 180-Day	HealthTronics OssaTron	HealthTronics Surgical Services, Inc. Marietta, GA 30062	Approval for insertion of a Table of adverse events and a brief paragraph following the post-approval study of ESW treatment of plantar fasciitis constituting the labeling changes in the Operating Manual.
P000012/S003 8/30/04 180-Day	COBAS AmpliPrep/ COBAS AMPLICOR HCV Test, v2.0	Roche Molecular Systems, Inc. Pleasanton, CA 94566	Approval for the COBAS AmpliPrep/ COBAS AMPLICOR HCV Test, v2.0 instrument which fully automates the specimen testing portion of the test.
P000013/S004 8/16/04 Real-Time	Osteonics ABC/Trident Systems	Howmedica Osteonics Corp. Mahwah, NJ 07432	Approval of the Trident “T” Shell for use with the Trident Alumina Insert. The Trident “T” Shell, which features a thicker shell wall, is a line extension to the Trident Acetabular Shells previously approved for use with the Trident Alumina Insert.
P000054/S002 8/9/04 Real-Time	InFUSE™ Bone Graft	Medtronic Sofamor Danek Memphis, TN 38132	Approval for expansion of the upper end of the storage temperature limit for the InFUSE Bone Graft component of the device from 25 degrees C to 30 degrees C. The device is indicated for treating acute, open tibial shaft fractures that have been stabilized with IM nail fixation after appropriate wound management. INFUSE Bone Graft must be applied within 14 days after the initial fracture. Prospective patients should be skeletally mature.
P010012/S024 8/6/04 180-Day	EASYTRAK ® 2, Models 4515/4517/4518/4520, EASYTRAK 2 IS-1, Models 4542/4543/4544, Coronary Venous Steroid Eluting Bipolar Pace/Sense Lead and EASYTRAK Finishing Wire, Model 6780	Guidant Corporation St. Paul, MN 55112	Approval for changes in lead lengths, addition of IS-1 connector and enabling bipolar pace/sense capability. The device, as modified, will be marketed under the trade name EASYTRAK 2 and is indicated for chronic, left ventricular pacing and sensing via the coronary veins, when used in conjunction with a compatible Guidant cardiac resynchronization therapy (CRT) device.
P010012/S025 8/6/04 180-Day	EASYTRAK ® 3 Coronary Venous Steroid Eluting Bipolar Pace/Sense Lead, Models 4522/4524/4525/ 4527	Guidant Corporation St. Paul, MN 55112	Approval for changes in fixation design, lead lengths and enabling bipolar pace/sense capability. The device, as modified, will be marketed under the trade name EASYTRAK 3 and is indicated for chronic, left ventricular pacing and sensing via the coronary veins, when used in conjunction with a compatible Guidant cardiac resynchronization therapy (CRT) device.
P010012/S029 8/6/04 Real-Time	Programmer Software Application Model 2845 version 2.4 for Contak Renewal and Contak Renewal 3	Guidant Corporation St. Paul, MN 55112	Approval for the Programmer Software Application Model 2845 version 2.4.
P010013/S008 8/13/04 Real-Time	NovaSure ® Impedance Controlled Endometrial Ablation System	Cytyc Surgical Product ® Palo Alto, CA 94303	Approval for modifications to the RF Controller, Model 09.
P010013/S009 8/2/04 Special	NovaSure ® Impedance Controlled Endometrial Ablation System	Cytyc Surgical Product ® Palo Alto, CA 94303	Approval for labeling changes.
P010015/S012 8/20/04 180-Day	Medtronic Left Ventricular Pacing Lead, Attain Bipolar OTW Model 4194	Medtronic, Inc. Minneapolis, MN 55432	Approval for modification to the coil and inner lumen. The device, as modified, will be marketed under the trade name Attain Bipolar OTW Model 4194 and is indicated for use as part of a Medtronic biventricular pacing system.
P010049/S012 8/31/04 Real-Time	SureStat Arterial Closure System	SUB-Q, Inc. San Clemente, CA 92673	Approval to add a polysaccharide (chitosan) to the hemostatic pledget formulation and requested to rename the device from the QuickSeal SureStat Arterial Closure System to the SureStat Arterial Closure System. The device, as modified, will be marketed under the trade name SureStat Arterial Closure System and is indicated for “…delivery of T-foam for extravascular closure of the femoral artery access sites. The system is indicated for use in reducing time to hemostasis 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.”
P010062/S001 8/2/04 Real-Time	Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb Vision Shaping Treatment	Bausch & Lomb Rohester, NY 14609	Approval for the protocol to be used to add contact lens finishing laboratories to manufacture the subject device. The device, as modified, will be marketed under the trade name Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb Vision Shaping Treatment and is 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 1.5 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.
P020006/S005 8/20/04 Special	Enteryx™ Procedure Kit	Boston Scientific Corporation Natick, MA 01760	Approval for changes to the physician and patient labeling which enhances information regarding adverse events.
P020023/S009 8/6/04 Real-Time	Restylane®	Q-Med Scandinavia, Inc. Princeton, NJ 08540	Approval for increasing the expiration dating for Restylane from 24 months to 36 months.
P020033/S001 8/27/04 Real-Time	INDEPENDENCE® iBOT™ 3000 Mobility System	Independence Technology, L.L.C. Warren, NJ 07059	Approval for a change to the design of the wheel cluster housing access port cap/cover as well as labeling changes to the User Manual that add a warning, a caution, and associated instructions regarding driving through debris.
P030002/S001 8/16/04 Real-Time	CrystaLens™ Model AT-45 Multipiece Silicone Posterior Chamber Accommodating Intraocular Lens (IOL)	C & C Vision Aliso Viejo, CA 92656	Approval for modifications to the physician’s labeling.
P030005/S003 8/6/04 Real-Time	Programmer Software Application Model 2865 version 1.9 for the Contak Renewal TR	Guidant Corporation St. Paul, MN 55112	Approval for Programmer Software Application Model 2865 version 1.9.
P030009/S001 8/4/04 Real-Time	Driver MX2 Coronary Stent System	Medtronic Vascular, Inc. Santa Rose, CA 95403	Approval for adding the MX2 Catheter to this product line. The device, as modified, will be marketed under the trade name Driver MX2 Coronary Stent System and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions with reference vessel diameters of 3.0 - 4.0 mm and 30 mm in length using direct stenting or pre-dilatation. Outcome beyond 270 days from this permanent implant is unknown at present.
P030019/S001 8/6/04 135-Day	Orthovisc ® High Molecular Weight Hyaluron	Anika Therapeutics Woburn, MA 01801	Approval for an alternate raw material source.
P030025/S001 8/6/04 135-Day	TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Approval for the addition of a new supplier for solvents used in the fabrication of the polymer coating for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System.
P030025/S004 8/18/04 Real-Time	TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Natick, MA 01760	Approval for extension of the product shelf life.
P030035/S001 8/16/04 Real-Time	Frontier II Model 5586 Biventricular Pulse Generator with the Model 3307, v4.8m Programmer Software	St. Jude Medical Sylmar, CA 91342	Approval for the Frontier II Model 5586 Biventricular Pulse Generator with the Model 3307, v4.8m programmer software.

30-Day Notices (135 Day Supplement was not required)

Summary of PMA Originals & Supplements Approved

Originals: 5
Supplements: 38

Summary of PMA Originals Under Review

Total Under Review: 83
Total Active: 32
Total On Hold: 51
Number Greater Than 180 Days: 2

Summary of PMA Supplements Under Review

Total Under Review: 196
Total Active: 99
Total On Hold: 97
Number Greater Than 180 Days: 3

Summary of All PMA Submissions Received

Originals: 3
Supplements: 62

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 38
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 110.1
FDA Time: 84.3 Days
MFR Time: 25.8 Days