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PMA Final Decisions Rendered for August 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, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| P020055 |
Ventana® Medical Systems PATHWAY Anti-c-KIT (9.7) Primary Antibody |
Ventana Medical Systems, Inc. |
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 |
Siemens Mammomat Novationdr Full Field Digital Mammography System |
Siemens Medical Solutions USA, Inc. |
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 |
ADVIA Centaur® HBc IgM ReadyPack Reagents, ADVIA Centaur® HBc IgM Quality Control Materials. |
Bayer Healthcare, LLC |
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 |
| P030050 |
Sculptra |
Aventis Pharmaceuticals, Inc. |
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,
AND2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion. |
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| P840002/S012 |
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. |
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 |
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. |
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 |
Thoratec ® Implantable Ventricular Assist Device (IVAD) |
Thoratec Corporation |
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 |
| P870072/S028 |
Thoratec® Paracorporeal ventricular Assist Device (PVAD) System and TLC-ii Portable VAD Driver |
Thoratec Corporation |
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 |
Hydrogenics ® 60 (Ocufilcon F) UV IMT Soft (Hydrophilic) Contact Lens for Extended Wear |
Ocular Science |
Approval for an alternate manufacturing site located at Ocular Sciences, Inc., Albuquerque New Mexico. |
| P890055/S017 |
Codman Model 3000 Series Constant Flow Implantable Pump |
Codman & Shurtleff, Inc. |
Approval for a manufacturing site located at Codman & Shurtleff, Inc., Raynham, Massachusetts. |
| P960016/S010 |
Livewire TC™ Cardiac Ablation System: Extension Cables Models 402506 and 402518 |
St. Jude Medical |
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 |
Livewire TC™ Cardiac Ablation System |
St. Jude Medical |
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 |
Perclose® ProGlide™ 6 Fr. Suture-Mediated Closure (SMC) System |
Abbott Vascular Devices |
Approval for revised instructions for use intended to enhance the safe use of the devices. |
| P960058/S036 |
HiResolution™ Bionic Ear System |
Advanced Bionics Corporation |
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 |
HiResolution™ Bionic Ear System |
Advanced Bionics Corporation |
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 |
Gynecare THERMACHOICE III Uterine Balloon Therapy System |
Gynecare |
Approval for labeling changes for the THERMACHOICE III. |
| P980016/S043 |
Medtronic Intrinsic Models 7287 and 7288 ICD Systems |
Medtronic, Inc. |
Approval for a RAMware update to the Medtronic Intrinsic Models 7287 and 7288 ICD Systems. |
| P980016/S044 |
Maximo VR Models 7232B and 7232E Implantable Cardioverter Defibrillators |
Medtronic, Inc. |
Approval for the addition of B and E connectors to the Maximo VR Model 7232. |
| P980035/S034 |
EnPulse Implantable Pulse Generator and Model 9991 Application Software |
Medtronic, Inc. |
Approval for a manufacturing site located at Medtronic Puerto Rico Operations Company, Juncos, Puerto Rico. |
| P980041/S006 |
Access® AFP Reagents on the Access Immunoassay Analyzer |
Beckman Coulter, Inc. |
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 |
HealthTronics OssaTron |
HealthTronics Surgical Services, Inc. |
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 |
COBAS AmpliPrep/ COBAS AMPLICOR HCV Test, v2.0 |
Roche Molecular Systems, Inc. |
Approval for the COBAS AmpliPrep/ COBAS AMPLICOR HCV Test, v2.0 instrument which fully automates the specimen testing portion of the test. |
| P000013/S004 |
Osteonics ABC/Trident Systems |
Howmedica Osteonics Corp. |
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 |
InFUSE™ Bone Graft |
Medtronic Sofamor Danek |
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 |
EASYTRAK ® 2, Models 4515/4517/4518/4520, EASYTRAK
2 IS-1, Models |
Guidant Corporation |
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 |
EASYTRAK ® 3 Coronary Venous Steroid Eluting Bipolar Pace/Sense Lead, Models 4522/4524/4525/ 4527 |
Guidant Corporation |
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 |
| P010012/S029 |
Programmer Software Application Model 2845 version 2.4 for Contak Renewal and Contak Renewal 3 |
Guidant Corporation |
Approval for the Programmer Software Application Model 2845 version 2.4. |
| P010013/S008 |
NovaSure ® Impedance Controlled Endometrial Ablation System |
Cytyc Surgical Product ® |
Approval for modifications to the RF Controller, Model 09. |
| P010013/S009 |
NovaSure ® Impedance Controlled Endometrial Ablation System |
Cytyc Surgical Product ® |
Approval for labeling changes. |
| P010015/S012 |
Medtronic Left Ventricular Pacing Lead, Attain Bipolar OTW Model 4194 |
Medtronic, Inc. |
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 |
SureStat Arterial Closure System |
SUB-Q, Inc. |
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 |
Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb Vision Shaping Treatment |
Bausch & Lomb |
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 |
Enteryx™ Procedure Kit |
Boston Scientific Corporation |
Approval for changes to the physician and patient labeling which enhances information regarding adverse events. |
| P020023/S009 |
Restylane® |
Q-Med Scandinavia, Inc. |
Approval for increasing the expiration dating for Restylane from 24 months to 36 months. |
| P020033/S001 |
INDEPENDENCE® iBOT™ 3000 Mobility System |
Independence Technology, L.L.C. |
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 |
CrystaLens™ Model AT-45 Multipiece Silicone Posterior Chamber Accommodating Intraocular Lens (IOL) |
C & C Vision |
Approval for modifications to the physician’s labeling. |
| P030005/S003 |
Programmer Software Application Model 2865 version 1.9 for the Contak Renewal TR |
Guidant Corporation |
Approval for Programmer Software Application Model 2865 version 1.9. |
| P030009/S001 |
Driver MX2 Coronary Stent System |
Medtronic Vascular, Inc. |
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 |
| P030019/S001 |
Orthovisc ® High Molecular Weight Hyaluron |
Anika Therapeutics |
Approval for an alternate raw material source. |
| P030025/S001 |
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System |
Boston Scientific Corporation |
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 |
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System |
Boston Scientific Corporation |
Approval for extension of the product shelf life. |
| P030035/S001 |
Frontier II Model 5586 Biventricular Pulse Generator with the Model 3307, v4.8m Programmer Software |
St. Jude Medical |
Approval for the Frontier II Model 5586 Biventricular Pulse Generator with the Model 3307, v4.8m programmer software. |
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| P960040/S045 8/17/04 |
VITALITY® ICDs |
Guidant CRM |
Change in the manufacturing process to expand the Guidant Clonmel, Ireland plant by adding Hybrid fabrication capability to the VITALITY family of devices. |
| P000028/S006 |
Affinity™ Anterior Cervical Cage System |
Medtronic Sofamor Danek |
Change of sterilization validation methods for the Affinity Anterior Cervical Cage System. |
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
Updated October 28, 2004
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Center for Devices and Radiological Health / CDRH
30
mm in length using direct stenting or pre-dilatation. Outcome beyond 270
days from this permanent implant is unknown at present.