Premarket Approval Decisions for January 2002

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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PMA Final Decisions Rendered for January 2002

Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for June 2002. 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 AND ZIP	DEVICE DESCRIPTION / INDICATIONS
P000048 01/15/02	Dornier Epos™ Ultra	Dornier Medical Systems, Inc. Kennesaw, GA 30144	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.
P010034 01/31/02	Second Look™	CADx Medical Systems, Inc. Northborough, MA 01532	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.
P010038 1/15/02	MammoReader	Intelligent Systems Software, Inc. Clearwater, FL 33759	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

P000048

01/15/02

Dornier Epos™ Ultra

Dornier Medical Systems, Inc.

Kennesaw, GA

30144

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.

P010034

01/31/02

Second Look™

CADx Medical Systems, Inc.

Northborough, MA

01532

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.

P010038

1/15/02

MammoReader

Intelligent Systems Software, Inc.

Clearwater, FL

33759

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.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE OF APPROVAL	DEVICE TRADE NAME	COMPANY NAME, CITY, STATE AND ZIP	DEVICE DESCRIPTION / INDICATIONS
P790018/S042 1/11/02 Special	Hall Easy-Fit™ Prosthetic Heart Valve, Models A7700 and M7700	Medtronic, Inc. Minneapolis, MN 55432	Approval to include one additional precaution statement to the Instructions for Use.
P850079/S039 1/17/02 180-Day	Expressions (methafilcon A) Soft (hydrophilic) Contact Lenses	CooperVision, Inc. Scottsville, NY 14546	Approval for an alternate facility for pad printing located at Aspect Vision Care, Southampton, United Kingdom.
P870072/S016 1/30/02 180-Day	Thoratec® Ventricular Assist Device (VAD) System	Thoratec Laboratories Corporation Pleasanton, CA 94588	Approval for a beveled-tip atrial cannula to replace the original atrial cannula design
P890023/S011 1/16/02 180-Day	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. Hampsire, UK	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 -10.00D sphere and pl to -6.00D cylinder. The lens may be prescribed for Daily or Extended Wear in not-aphakic persons. When prescribing for extended wear, the eye care practitioner may recommend lens wear up to 7 days / 6 nights between removals for cleaning and disinfection. The eye care practitioner may prescribe the contact lens for either single use disposable wear or for scheduled replacement wear, with cleaning, disinfection, and schedules replacement. When prescribing for scheduled replacement wear, the contact lens may be disinfected using a chemical (not heat) disinfecting system. Hydrogenics 60 (ocufilcon F) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
P890057/S015 1/8/02 180-Day	Model 3100B High-Frequency Oscillatory Ventilator (HFOV)	SensorMedics Corporation Yorba Linda, CA 92887	Approval of a modification to the design of the driver diaphragm in the device.
P900043/S032 1/31/02 Special	BX Velocity Stent with HEPACOAT on RaptoRail and Raptor Stent Delivery Systems	Cordis Corp. Warren, NJ 07059	Approval for modifications to the labeling, adding several warnings for opening the packaging.
P900056/S067 1/9/02 180-Day	Rotablator Rotational Angioplasty System Guide Wires	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Approval for an alternate sterilization facility located at the Cosmed Group, Inc., Coventry, Rhode Island.
P900066/S005 1/29/02 Special	Perfluoropropane Gas for Pneumatic Retinopexy	Scott Medical Products Plumsteadville, PA 18949	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 1/29/02 Special	Sulfur Hexafluoride Gas for Pneumatic Retinopexy	Scott Medical Products Plumsteadville, PA 18949	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 1/11/02 Real-Time	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 St. Paul, MN 55112	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 1/10/02 180-Day	WALLSTENT® (TIPS, Iliac, Venous) Endoprosthesis with Unistep Plus Delivery Systems	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	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 1/10/02 180-Day	WALLSTENT® (TIPS, Iliac, Venous) Endoprosthesis with Unistep Plus Delivery Systems	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	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 1/25/02 Special	Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test (MTD Test)	Gen-Probe Inc. San Diego, CA 92121	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 1/23/02 180-Day	SILIKON™ 1000	Alcon Laboratories Fort Worth, TX 76134	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 1/23/02 180-Day	Cutting Balloon	Interventional Technologies, Inc. San Diego, CA 92123	Approval for the following modifications to the device: modification of the design and materials of construction of the Y-site assembly; change in the composition of the guidewire lumen tubing; new packaging configuration and materials; and use of an alternative sterilizer
P950032/S028 1/17/02 180-Day	Apligraf	Organogenesis, Inc. Canton, MA 02021	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 1/18/02 180-Day	NeuroControl Freehand® II System	NeuroControl Corporation Valley view, OH 44125	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.
P960009/S007 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 1/3/02 180-Day	Soft-55 EW Aphakic (vifilcon A) Soft (hydrophilic) Spherical Contact Lens For Extended Wear	Unilens Corporation, USA Largo, FL 33777	Approval for the manufacturing facility located at Unilens Corporation, USA, Largo, Florida.
P960042/S007 1/25/02 180-Day	16F Laser Sheath Kit	Spectranetics Corporation Colorado Springs, CO 80907	Approval for a modification to the 16F Laser Sheath Kit.
P970020/S035 1/14/02 Real-Time	ACS MULTI-LINK RX and OTW ULTRA™ Coronary Stent System	Guidant Corporation Santa Clara, CA 95054	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: Patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions (length <=25 mm) with reference vessel diameters ranging from 3.5 mm to 5.0 mm; Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length <=35mm) with reference vessel diameters ranging from 3.5 mm to 5.0 mm; and Treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions (<=35 mm in length) with reference diameters in the range of 3.5 mm to 5.0 mm. Long term outcome for this permanent implant is unknown at present. Note: 38 mm length stents are solely indicated for use in patients with abrupt of threatened abrupt closure and patients with lesions in saphenous vein bypass grafts
P970020/S036 1/14/02 Real-Time	ACS MULTI-LINK RX and OTW PENTA™ Coronary Stent System	Guidant Corporation Santa Clara, CA 95054	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: Patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions (length <=25 mm) with reference vessel diameters ranging from 3.0 mm to 4.0 mm; Patients with symptomatic ischemic heart disease die to lesions in saphenous vein bypass grafts (length <=35 mm) with reference vessel diameters ranging from 3.0 mm to 4.0 mm; and Treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions (<=35 mm in length) with reference diameters in the range of 2.5 mm to 4.0 mm. Long term outcome for this permanent implant is unknown at present. 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 1/31/02 Real-Time	Medtronic AVE S660 2.75 with Discrete Technology™ Over-the-Wire Coronary Stent System	Medtronic AVE, Inc. Santa Rosa, CA 95403	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 1/7/02 180-Day	Nucleus 24 Cochlear Implant System	Cochlear Corporation Englewood, CO 80112	Approval for the most recent software version for the Neural Response Telemetry (NRTV3) to be used with this device.
P970061/S013 1/22/02 180-Day	Magic Wallstent® Endoprosthesis and Radius™ Coronary Stent with Delivery System	Boston Scientific Corporation Maple Grove, MN 55311	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 1/8/02 180-Day	Chilli® Cooled Ablation System	Cardiac Pathways Corporation Sunnyvale, CA 94086	Approval for the additional manufacturing facility located at Boston Scientific Corporation, San Jose, California.
P980009/S010 1/22/02 180-Day	Magic Wallstent® Endoprosthesis and Radius™ Coronary Stent with Delivery System	Boston Scientific Corporation Maple Grove, MN 55311	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 1/18/02 Real-Time	GEM DR Model 7271, GEM II DR Model 7273 and GEM III DR Model 7275	Medtronic, Inc. Minneapolis, MN 55432	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 1/10/02 180-Day	WALLSTENT® (TIPS, Iliac, Venous) Endoprosthesis with Unistep Plus Delivery Systems	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	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 1/11/02 Real-Time	ELAVIEW 1.06 UG1	LLA Medical, LLC Plymouth, MN 55441	Approval for the application software ELAVIEW 1.06 UGI of the Orchestra Programmer.
P980050/S011 1/18/02 Real-Time	GEM III AT Model 7276	Medtronic, Inc. Minneapolis, MN 55432	Approval for a design change to the connector assembly for the GEM III AT Model 7276.
P990054/S003 1/8/02 180-Day	Chilli® Cooled Ablation System	Cardiac Pathways Corporation Sunnyvale, CA 94086	Approval for the additional manufacturing facility located at Boston Scientific Corporation, San Jose, California.
P990064/S006 1/18/02 180-Day	Medtronic Mosaic® Procine Bioprosthesis, Model 305 (aortic)	Medtronic Heart Valves Santa Ana, CA 92705	Approval for The Mosaic® Porcine Bioprosthesis, Model 305 Aortic, 19 mm.
P000015/S002 1/7/02 180-Day	Nucleus 24 Auditory Brainstem Implant System	Cochlear Corporation Englewood, CO 80112	Approval for the most recent software version for the Neural Response Telemetry (NRTV3) to be used with this device.
P000018/S016 1/30/02 Real-Time	Novoste™ Beta-Cath™ System	Novoste Corporation Norcross, GA 30093	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 1/28/02 Real-Time	Stinger, Stinger S, Stinger M and Stinger SM Ablation Catheters	C.R. Bard, Inc. Lowell, MA 01851	Approval to add the Reuse Claim to the labeling for the Bard Electrophysiology TempLink™ and TempLink™ M Extension Cables.
P000043/S002 1/11/02 Real-Time	TMx-2000™ BPH Thermotherapy System	TherMatrx, Inc. Northbrook, IL 60062	Approval for design changes to the Rx-200 Applicator of the TMx-2000™ BPH Thermotherapy System.
P010016/S002 1/17/02 Real-Time	OrCel™ Bilayered Cellular Matrix	Ortec International, Inc. New York, NY 10032	Approval for use of cell line FS-183 in the commercial manufacture of OrCel™ Bilayered Cellular Matrix.

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

APPLICATION NUMBER / DATE OF APPROVAL	DEVICE TRADE NAME	COMPANY NAME, CITY, STATE AND ZIP	DEVICE DESCRIPTION / INDICATIONS
P840001/S060 1/3/02	Itrel Spinal Cord Stimulation 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.
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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Center for Devices and Radiological Health / CDRH