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Device | ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S014 |
Date Received | 01/11/1996 |
Decision Date | 05/16/1996 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE SUPPORT ROTAWIRE AND RAIL ROTAWIRE GUIDE WIRES FOR USE WITH THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM |