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PMA Final Decisions Rendered for January 2002 |
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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 |
---|---|---|---|
01/15/02 |
Dornier Epos Ultra |
Dornier Medical Systems, Inc. |
Approval for the Dornier Epos Ultra. The Dornier Epos Ultra is a non-surgical alternative for the treatment of chronic plantar fasciitis for patients with symptoms of plantar fasciitis for 6 months or more and a history of unsuccessful conservative therapy. Plantar fasciitis is defined as the traction degeneration of the plantar fascial band at its origin on the medical tubercle of the calcaneus. |
01/31/02 |
Second Look |
CADx Medical Systems, Inc. |
Approval for the Second Look. The Second Look Computer-aided detection system for mammography is intended to identify and mark regions of interest on standard mammographic views to bring them 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. |
1/15/02 |
MammoReader |
Intelligent Systems Software, Inc. |
Approval for the MammoReader. The MammoReader is a computer system intended to identify and mark regions of interest on standard mammographic views to bring them 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. |
APPLICATION NUMBER / DATE OF APPROVAL | DEVICE TRADE NAME | COMPANY NAME, CITY, STATE AND ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P790018/S042 |
Hall Easy-Fit Prosthetic Heart Valve, Models A7700 and M7700 |
Medtronic, Inc. |
Approval to include one additional precaution statement to the Instructions for Use. |
P850079/S039 |
Expressions (methafilcon A) Soft (hydrophilic) Contact Lenses |
CooperVision, Inc. |
Approval for an alternate facility for pad printing located at Aspect Vision Care, Southampton, United Kingdom. |
P870072/S016 |
Thoratec® Ventricular Assist Device (VAD) System |
Thoratec Laboratories Corporation |
Approval for a beveled-tip atrial cannula to replace the original atrial cannula design |
P890023/S011 |
Hydrogenics® 60 (ocufilcon F) UV IMT Contact Lens for Extended Wear (up to 7 days/6 nights of Extended Wear) (Spherical and Toric) |
Ocular Sciences, Inc. |
Approval for the Hydrogenics 60 (ocufilcon F) UV In-monomer tint contact
lens indicated for extended wear (up to 7 days / 6 nights between removals
for cleaning and disinfection). The device, as modified, will be marketed
under the trade name referenced above with the following indications:
SPHERICAL: Hydrogenics 60 (ocufilcon F) UV Blocking Contact Lenses are
indicated for the correction of visual acuity in persons with non-diseased
eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit
refractive astigmatism up to 2.00 diopters that does not interfere with
visual acuity. TORIC: Hydrogenics (ocufilcon F) UV Blocking Contact Lenses
are indicated for the correction of visual acuity in persons with non-diseased
eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit
refractive astigmatism of up to -6.00 diopters. The overall power range
is +8.00D to |
P890057/S015 |
Model 3100B High-Frequency Oscillatory Ventilator (HFOV) |
SensorMedics Corporation |
Approval of a modification to the design of the driver diaphragm in the device. |
P900043/S032 |
BX Velocity Stent with HEPACOAT on RaptoRail and Raptor Stent Delivery Systems |
Cordis Corp. |
Approval for modifications to the labeling, adding several warnings for opening the packaging. |
P900056/S067 |
Rotablator Rotational Angioplasty System Guide Wires |
Boston Scientific Scimed, Inc. |
Approval for an alternate sterilization facility located at the Cosmed Group, Inc., Coventry, Rhode Island. |
P900066/S005 |
Perfluoropropane Gas for Pneumatic Retinopexy |
Scott Medical Products |
Approval for labeling modifications to improve the patient's and doctor's knowledge regarding the hazards of using Nitrous Oxide for a subsequent surgical procedure when gas is still present in the eye. |
P900067/S003 |
Sulfur Hexafluoride Gas for Pneumatic Retinopexy |
Scott Medical Products |
Approval for labeling modifications to improve the patient's and doctor's knowledge regarding the hazards of using Nitrous Oxide for a subsequent surgical procedure when gas is still present in the eye. |
P910073/S038 |
PEEK Support Clip for the ENDOTAK DSP Lead Models 0094, 0095, 0125, ENDOTAK ENDURANCE Lead Models 0134, 0135, 0136 and ENDOTAK ENDURANCE EZ Lead Models 0154, 0155 and 0156 |
Guidant Corporation |
Approval for the PEEK Support Clip for the ENDOTAK DSP Lead Models 0094, 0095, 0125, ENDOTAK ENDURANCE Lead Models 0134, 0135, 0136 and ENDOTAK ENDURANCE EZ Lead Models 0154, 0155 and 0156. |
P930031/S011 |
WALLSTENT® (TIPS, Iliac, Venous) Endoprosthesis with Unistep Plus Delivery Systems |
Boston Scientific Scimed, Inc. |
Approval for an alternate manufacturing facility located at Boston Scientific Ireland Ltd. (BSIL), Galway, Ireland and an alternate sterilization facility located at Isotron, Offaly, Ireland. |
P940019/S009 |
WALLSTENT® (TIPS, Iliac, Venous) Endoprosthesis with Unistep Plus Delivery Systems |
Boston Scientific Scimed, Inc. |
Approval for an alternate manufacturing facility located at Boston Scientific Ireland Ltd. (BSIL), Galway, Ireland and an alternate sterilization facility located at Isotron, Offaly, Ireland. |
P940034/S013 Special |
Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test (MTD Test) |
Gen-Probe Inc. |
Approval for changes to the Relative Light Units (RLU) specification for the 0.2-0.3 mm Washed Glass Beads (Part No. 101321) and Filled Lysing Tubes (Part No. 102606). |
P950008/S003 |
SILIKON 1000 |
Alcon Laboratories |
Approval for modification of the molecular weight range specification for SILIKON 1000 from 36,000 - 48,000 Dalton to 32,850 - 47,000 Dalton. |
P950020/S003 |
Cutting Balloon |
Interventional Technologies, Inc. |
Approval for the following modifications to the device:
|
P950032/S028 |
Apligraf |
Organogenesis, Inc. |
Approval for removal of the CMV IgG antibody test from the antepartum maternal donor serum testing panel, while continuing to test the maternal donor sera for CMV IgM antibodies and the Master Cell Bank for CMV via PCR. |
P950035/S009 |
NeuroControl Freehand® II System |
NeuroControl Corporation |
Approval for the Universal External Controller (UEC), revised Freehand® Clinician Programming Interface Software, Version 5.0, which are used to operate and program the Freehand® Implantable-Receiver Stimulator, and subsequent changes to the labeling. The device, as modified, will be marketed under the trade name Freehand® II System. |
1/14/02 Panel |
Medtronic Activa®Parkinson's Control Therapy | Medtronic Neurological Minneapolis MN 55421 |
Approval for the Medtronic Activa Parkinson's Control Therapy which includes the Model 3387 DBS Lead, Model 3389 DBS Lead, Model 7482 Extension, Model 7495 Extension, Model 7426 Soletra Neurostimulator, Burr Hole Ring and Cap, Model 7432 Physician Programmer, Model 7460 MemoryMod Software Cartridge, Model 7452 Patient Magnet, Model 3625 Test Stimulator, Model 3353/3354 Lead Frame Kit, and Accessories. The device is indicated for bilateral stimulation of the internal globus pallidus (Gpi) or the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. |
P960039/S002 |
Soft-55 EW Aphakic (vifilcon A) Soft (hydrophilic) Spherical Contact Lens For Extended Wear |
Unilens Corporation, USA |
Approval for the manufacturing facility located at Unilens Corporation, USA, Largo, Florida. |
P960042/S007 |
16F Laser Sheath Kit |
Spectranetics Corporation |
Approval for a modification to the 16F Laser Sheath Kit. |
P970020/S035 |
ACS MULTI-LINK RX and OTW ULTRA Coronary Stent System |
Guidant Corporation |
Approval for the addition of an indication to use the 4.5 mm and 5.0 mm ULTRA OTW and RX for the treatment of saphenous vein graft (SVG) lesions. The MULTI-LINK RX ULTRA and MULTI-LINK OTW ULTRA Coronary Stent System will include the following indication:
|
P970020/S036 Real-Time |
ACS MULTI-LINK RX and OTW PENTA Coronary Stent System |
Guidant Corporation |
Approval for the addition of an indication to use the 3.0 mm to 4.0 mm ULTRA OTW and RX for the treatment of SVG lesions. The MULTI-LINK RX PENTA and MULTI-LINK OTW PENTA Coronary Stent System will include the following indication:
Note: The 2.5 mm and 2.75 mm stents are solely indicated for use in patients with abrupt or threatened abrupt closure. The 33 mm and 38 mm length stents are indicated solely for use in patients with abrupt or threatened abrupt closure and patients with lesions in saphenous vein bypass grafts. |
P970035/S032 |
Medtronic AVE S660 2.75 with Discrete Technology Over-the-Wire Coronary Stent System |
Medtronic AVE, Inc. |
Approval for the Medtronic AVE S660 2.75 with Discrete Technology Over-the-Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in the treatment of acute or threatened closure during a planned interventional procedure in de novo lesions (<=24 mm in length) in native coronary artery or arterial bypass graft conduit with a reference diameter between 2.2 mm and 2.9 mm. Long-term outcome (beyond 30 days) for this implant is unknown at present. |
P970051/S018 |
Nucleus 24 Cochlear Implant System |
Cochlear Corporation |
Approval for the most recent software version for the Neural Response Telemetry (NRTV3) to be used with this device. |
P970061/S013 |
Magic Wallstent® Endoprosthesis and Radius Coronary Stent with Delivery System |
Boston Scientific Corporation |
Approval for two alternate manufacturing facilities for packaging and labeling operations located at Boston Scientific Corporation, Quincy, Massachusetts and Boston Scientific European Distribution Center, Beek, The Netherlands. |
P980003/S004 180-Day |
Chilli® Cooled Ablation System |
Cardiac Pathways Corporation |
Approval for the additional manufacturing facility located at Boston Scientific Corporation, San Jose, California. |
P980009/S010 |
Magic Wallstent® Endoprosthesis and Radius Coronary Stent with Delivery System |
Boston Scientific Corporation |
Approval for two alternate manufacturing facilities for packaging and labeling operations located at Boston Scientific Corporation, Quincy, Massachusetts and Boston Scientific European Distribution Center, Beek, The Netherlands. |
P980016/S025 |
GEM DR Model 7271, GEM II DR Model 7273 and GEM III DR Model 7275 |
Medtronic, Inc. |
Approval for a design change to the connector assembly for the GEM DR Model 7271, GEN II DR Model 7273 and GEM III DR Model 7275. |
P980033/S001 |
WALLSTENT® (TIPS, Iliac, Venous) Endoprosthesis with Unistep Plus Delivery Systems |
Boston Scientific Scimed, Inc. |
Approval for an alternate manufacturing facility located at Boston Scientific Ireland Ltd. (BSIL), Galway, Ireland and an alternate sterilization facility located at Isotron, Offaly, Ireland. |
P980049/S007 |
ELAVIEW 1.06 UG1 |
LLA Medical, LLC |
Approval for the application software ELAVIEW 1.06 UGI of the Orchestra Programmer. |
P980050/S011 |
GEM III AT Model 7276 |
Medtronic, Inc. |
Approval for a design change to the connector assembly for the GEM III AT Model 7276. |
P990054/S003 |
Chilli® Cooled Ablation System |
Cardiac Pathways Corporation |
Approval for the additional manufacturing facility located at Boston Scientific Corporation, San Jose, California. |
P990064/S006 |
Medtronic Mosaic® Procine Bioprosthesis, Model 305 (aortic) |
Medtronic Heart Valves |
Approval for The Mosaic® Porcine Bioprosthesis, Model 305 Aortic, 19 mm. |
P000015/S002 |
Nucleus 24 Auditory Brainstem Implant System |
Cochlear Corporation |
Approval for the most recent software version for the Neural Response Telemetry (NRTV3) to be used with this device. |
P000018/S016 |
Novoste Beta-Cath System |
Novoste Corporation |
Approval for the revised post-approval study protocol for the 30 mm and 40 mm Beta-Cath Systems. The revised post-approval study is intended to verify that the corrective actions, intended to help minimize the incidence of device failures and malfunctions seen during the premarket clinical investigations, are successful in reducing the device failure and malfunction rate. |
P000020/S006 |
Stinger, Stinger S, Stinger M and Stinger SM Ablation Catheters |
C.R. Bard, Inc. |
Approval to add the Reuse Claim to the labeling for the Bard Electrophysiology TempLink and TempLink M Extension Cables. |
P000043/S002 Real-Time |
TMx-2000 BPH Thermotherapy System |
TherMatrx, Inc. |
Approval for design changes to the Rx-200 Applicator of the TMx-2000 BPH Thermotherapy System. |
P010016/S002 |
OrCel Bilayered Cellular Matrix |
Ortec International, Inc. |
Approval for use of cell line FS-183 in the commercial manufacture of OrCel Bilayered Cellular Matrix. |
APPLICATION NUMBER / DATE OF APPROVAL | DEVICE TRADE NAME | COMPANY NAME, CITY, STATE AND ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P840001/S060 |
Itrel Spinal Cord Stimulation System |
Medtronic, Inc. |
Change in the controlled environmental area (CEA) from a Class 10,000 environment to a Class 100,000 environment. |
P890003/S067 1/3/02 |
Thera/Thera-i Implantable Pulse Generator, Model 8158 | Medtronic, Inc. Minneapolis, MN 55432 |
Change in a controlled environmental area from Class 10,000 to a minimum of Class 100,000. |
P950008/S004 1/3/02 |
Silikon 1000 | Alcon Research, Ltd. Fort Worth, TX 76134 |
Modification of testing methodology for low molecular weight siloxanes determination in Silikon 1000. |
P960009/S023 1/3/02 |
Activa Tremor Control System | Medtronic, Inc. Minneapolis, MN 55421 |
Change in the controlled environmental area (CEA) from a Class 10,000 environment to a Class 100,000 environment. |
P990033/S003 1/25/02 |
PepGen P-15 and PepGen P-15 Flow | DENTSPLY CeraMed Dental Lakewood, CO 80228 |
Change in manufacturer/ vendor for the P-15 peptide. |
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 38
Summary of PMA Originals Under Review
Total Under Review: 64
Total Active: 29
Total On Hold: 35
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 255
Total Active: 167
Total On Hold: 88
Number Greater Than 180 Days: 8
Summary of All PMA Submissions Received
Originals: 4
Supplements: 45
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): 115.5
FDA Time: 91.1 Days
MFR Time: 24.4 Days
Updated 2/28/2002
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