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Device | ROTAWIRE FLOPPY GOLD GUIDE WIRE/ROTABLATOR SYSTEMS GUIDE WIRE LINE |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S022 |
Date Received | 11/07/1997 |
Decision Date | 08/06/1998 |
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 RotaWire(TM) Floppy Gold Guide Wire for use with the Rotablator(R) Rotational Angioplasty System. |