In Brief: Circulatory System Devices Panel
This article was originally published in The Gray Sheet
Executive Summary
Circulatory System Devices Panel: Premarket approval application for Spectranetics' model 500-001 fiber optic Laser Sheath pacemaker and defibrillator lead removal device slated for review at July 29 meeting at the Holiday Inn in Gaithersburg, Maryland. The Laser Sheath, granted expedited review status by the agency in November 1996, is designed for use with Spectranetics' CVS-300 excimer laser unit to remove pacemaker and implantable cardioverter defibrillator leads by ablating through scar tissue with fiberoptic laser energy. The panel will also be meeting on July 28 to discuss a PMA for PLC Systems' Heart Laser transmyocardial revascularization system ("The Gray Sheet" May 26, In Brief)...
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