A meeting of the Circulatory System Devices Panel was held on June 19 and 20, 2000.
On June 19, the Panel reviewed a PMA (P990036) for the Cordis Checkmate™ System. The device is an intravascular radiation system indicated for the treatment of instent restenosis. The Panel recommendation was approvable with conditions by a ten to zero vote. The Panel identified measures that were necessary to place the application in an approvable form.
There were no speakers during the Open Public Hearing.
On June 20, the Panel discussed a FDA proposed modification to the guidance document titled, "DRAFT Guidance for Implantable Cardioverter Defibrillators", that would allow manufacturers of implantable cardioverter defibrillators to obtain generic indications for use.
During the Open Public Hearing, the Panel heard comments from the North American Society for Pacing and Electrophysiology (NASPE), Medtronic, Inc, and Guidant Corporation. The speakers expressed their support for FDA’s proposed modification.
Contact: Megan Moynahan, Executive Secretary, 301-443-8517, 171
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