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PMA Final Decisions Rendered for July 2000

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 July 2000. 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

PMA/PDP SUPPLEMENTAL APPROVALS
APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P850051/S055 7/21/00 Real-Time	Prevail Model 8085 Pulse Generator	Medtronic, Inc. Minneapolis, MN 55432	Approval for the use of header part number 149422-002 in the following pulse generators: Prevail Model 8085, Preva SR Model 8089, Prodigy S Model 8165, Prodigy SR Model 8161, Thera-I S Model 8965I, There-I SR Model 8961I, Vitatron Visa S Model 115 and Vitatron Visa SR Model 415.
P860026/S006 7/7/00 180-Day	Diaphragmatic/ Phrenic Nerve Stimulator	Avery Laboratories, Inc. Commack, NY 11725	Approval for process validation of the proposed device sterilization procedure, proposed labeling for the device packaging, and the proposed changes to the instruction manual. The device, as modified, will be marketed under the trade name Mark IV and is indicated for persons who require chronic ventilatory support because of upper motor neuron respiratory muscle paralysis(RMP) or because of central alveolar hypoventilation (CAH) and whose remaining phrenic nerve, lung, and diaphragm function is sufficient to accommodate electrical stimulation.
P870015/S036 7/26/00 Real-Time	Medstone STS-T Lithotripter	Medstone International, Inc. Aliso Viejo, CA 92656	Approval for minor software upgrades (version 2000.0) and associated changes to the device labeling.
P870018/S025 7/17/00 Real-Time	Mobile Configuration of Lithostar Modularis	Siemens Medical Systems, Inc. Iselin, NJ 08830	Approval for the mobile configuration of the Lithostar Modularis.
P880003/S080 7/7/00 180-Day	Ninja(fx) Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheters	Cordis Corporation Miami, FL 33102	Approval for Ninja(fx) PTCA Dilatation Catheter with the following balloon sizes: 1.5 mm x 20 mm, 25 mm, and 30 mm, 2.0 mm x 20 mm, 25 mm, and 30 mm; 2.25 mm – 4.0 mm (in ¼ mm sizes) x 10 mm, 15 mm, 18 mm, 20 mm, 25 mm, and 30 mm; 4.5 mm x 20 mm; and 5.0 mm x 20 mm. The Ninja(fx) PTCA Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P890003/S060 7/21/00 Real-Time	Synergist II Family of Pulse Generators	Medtronic, Inc. Minneapolis, MN 55432	Approval for the use of header part number 149422-002 in the following pulse generators: Prevail Model 8085, Preva SR Model 8089, Prodigy S Model 8165, Prodigy SR Model 8161, Thera-I S Model 8965I, There-I SR Model 8961I, Vitatron Visa S Model 115 and Vitatron Visa SR Model 415.
P890017/S008 7/11/00 180-Day	PALMAZ™ Balloon Expandable Stent	Cordis Corporation Miami, FL 33102	Approval to modify the device labeling to specify the Cordis Maxi DS Balloon Catheter as the recommended delivery system for the P308 PALMAZ™ balloon expandable stent.
P890017/S009 7/11/00 Special	PALMAZ™ Balloon Expandable Stent	Cordis Corporation Miami, FL 33102	Approval for a revised Instructions for Use (IFU) for the Cordis PALMAZ™ balloon expandable stent.
P900043/S024 7/21/00 180-Day	BX VELOCITY™ with HEPACOAT™ on Raptor™ Stent System	Cordis Corporation Warren, NJ 07059	Approval for the addition of a heparin coating to the BX VELOCITY™ Coronary Stent. The device, as modified, will be marketed under the trade name BX VELOCITY™ with HEPACOAT™ on Raptor™ Stent System and is indicated for improving coronary luminal diameter in the treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (<=30 mm in length) with reference diameters in the range of 2.25 to 4.00 mm.
P900056/S047 7/11/00 Special	Rotablator Rotational Angioplasty System	Boston Scientific Corporation Redmond, WA 98052	Approval for a quality control change to ensure adequate inspection of guide wires for the appropriate application of lubricant.
P900056/S048 7/21/00 Real-Time	Rotablator® RotaLink Rotational Angioplasty System	Boston Scientific Corporation Redmond, WA 98052	Approval for the use of a modified formed catheter tube in the Rotablator® RotaLink System.
P900056/S049 7/27/00 Special	Rotablator Rotational Angioplasty System	Boston Scientific Corporation Redmond, WA 98052	Approval for quality control change to the steps involved in installation and inspection of the infusion hose.
P900056/S052 7/27/00 Special	Rotablator Rotational Angioplasty System	Boston Scientific Corporation Redmond, WA 98052	Approval for a quality control change to add a package label verification step at guide wire packaging.
P910001/S015 7/11/00 180-Day	Extreme 0.9 mm Coronary Angioplasty Catheter	Spectranetics Corporation Colorado Springs, CO 80907	Approval for the Extreme 0.9 mm Coronary Angioplasty Catheter.
P920014/S011 7/20/00 180-Day	HeartMate® IP and VE LVAS	Thermo Cardiosystems, Inc. Woburn, MA 01888	Approval of the protocol to be used to extend the shelf life from 2 years to 3 years for products that are ethylene oxide (EO) sterilized for several types of packaging.
P930029/S014 7/31/00 Real-Time	RF Conductr® MC – 5 mm Catheter Models 6042 and 7544	Medtronic EP Systems Shoreview, MN 55126	Approval for a modification to the tip electrode length (5 mm). The device, as modified, will be marketed under the trade name Conductr® MC-5mm, and is indicated for the interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia, for the treatment of AV nodal re-entrant tachycardia, and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.
P930038/S025 7/17/00 180-Day	6F Angio-Seal™ Hemostatic Puncture Closure Device	St. Jude Medical Minnetonka, MN 55345	Approval for a modification to the deployment force specification.
P940010/S008 7/7/00 180-Day	OPTIGUIDE Fiber Optic Diffuser (DCYL2)	QLT PhotoTherapeutics, Inc. Washington, DC 20014	Approval for the addition of Surgical Technologies, Inc. as an alternate packaging and sterilization site, and modifications to the fiber optic reel and primary packaging box.
P940022/S014 7/13/00 180-Day	CLARION® Multi-Strategy Cochlear Implant (Adult) HiFocus Electrode with Electrode Positioner	Advanced Bionics® Corporation Sylmar, CA 91342	Approval for the CLARION® Multi-Strategy Cochlear Implant HiFocus Electrode for post-lingual severe to profound hearing loss where limited benefit has been obtained with the use of hearing aids.
P950008/S001 7/11/00 Real-Time	SILIKON 1000	Alcon Research, Ltd. Fort Worth, TX 76134	Approval for a modification to the molecular weight specification range.
P950022/S009 7/6/00 Real-Time	TVL Right Ventricular (RV) Lead Models RV06 and RV07	St. Jude Medical Sunnyvale, CA 94086	Approval for the TVL Right Ventricular (RV) Lead Models RV06 and RV07.
P950034/S016 7/7/00 Real-Time	Seprafilm™ Bioresorbable Membrane	Genzyme Corporation Cambridge, MA 02139	Approval for elimination of the rat cecal abrasion bioassay as a finished product release criterion and as a stability test.
P950035/S006 7/5/00 180-Day	NeuroControl Freehand™ System	NeuroControl Corporation Valley View, OH 44125	Approval for the distribution of an Intramuscular Electrode and Intramuscular Electrode Insertion Tool Kit as components to the Freehand™ System, and labeling changes.
P960040/S014 7/13/00 Real-Time	VENTAK PRIZM Model 2844 Software Application, Versions 1.5 and 2.3	Guidant Corporation St. Paul, MN 55112	Approval for the software that controls Program/Recorder/Monitors Models 2901 and 2910.
P970003/S026 7/19/00 Real-Time	NeuroCybernetic Prosthesis (NCP®) System, Model 400s NCP Tunneling Tool	Cyberonics, Inc. Houston, TX 77058	Approval for the Model 400S NCP Tunneling Tool (for use with the NCP System).
P970015/S013 7/11/00 180-Day	INTER FIX™ Threaded Fusion Device – Post Approval Study	Medtronic Sofamor Danek Memphis, TN 38132	Approval of a post approval study for the INTER FIX™ Threaded Fusion Device.
P970043/S008 7/11/00 180-Day	Summit Autonomous LADARVision 4000 Laser System	Summit Autonomous, Inc. Orlando, FL 32826	Approval for the corresponding company name change, device name change, and some external changes to the device. The device, as modified, will be marketed under the trade name Summit Autonomous LADARVision 4000 Laser System.
P970051/S008 7/11/00 180-Day	Nucleus CI24M Cochlear Implant	Cochlear Corporation Englewood, CO 80112	Approval for a manufacturing site located at Griffith Analytical, Burr Ridge, Illinois.
P970058/S008 7/5/00 180-Day	ImageChecker M1000	R2 Technology, Inc. Los Altos, CA 94022	Approval for the addition of a new mass marker. This marker (a circle) is intended to enable the user of the ImageChecker to differentiate obvious masses from more subtle masses that appear in analyzed mammograms.
P980001/S014 7/13/00 180-Day	NIROYAL™ Advance Premounted Stent System	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Approval for the 4.5 and 5.0 mm diameter NIROYAL™ Advance Premounted Stent Systems.
P980001/S021 7/14/00 180-Day	NIR® Premounted Stent Systems	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Approval for an alternate contract sterilization facility located at IBA (formerly Griffith Micro Science, Inc.), Willowbrook, Illinois, 60521.
P990001/S003 7/26/00 180-Day	Selection AFm 902 Pulse Generator and the Model VSA02, Version 6.0 Programmer Software	Vitatron, Inc. Minneapolis, MN 55459	Approval for the parylene coated version of the Selection AFm 902 Pulse Generator and the Model VSA02, Version 6.0 programmer software.
P990071/S001 7/21/00 180-Day	Stockert 70 RF Generator and Accessories	Biosense Webster, Inc. Diamond Bar, CA 91765	Approval for a change in manufacturing facility address to Stockert GmbH, Freiburg, Germany.

 

Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 33

Summary of PMA Originals Under Review
Total Under Review: 82
Total Active: 44
Total On Hold: 38
Number Greater Than 180 Days: 0

Summary of PMA Supplements Under Review
Total Under Review: 184
Total Active: 108
Total On Hold: 76
Number Greater Than 180 Days: 4

Summary of All PMA Submissions Received
Originals: 7
Supplements: 39

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 33
Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 91.5
FDA Time: 72.1 Days
MFR Time: 19.5 Days

  Updated 9/20/2000

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