Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM CONSOLE AND DYNAGLIDE(TM)FOOT PEDAL |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S064 |
Date Received | 05/30/2001 |
Decision Date | 09/07/2001 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITIES LOCATED AT PLEXUS CORPORATION, BOTHELL, WASHINGTON FOR THE MANUFACTURE OF THE ROTABLATOR(R) CONSOLE AND DYNAGLIDE(TM) FOOT PEDAL AND BOSTON SCIENTIFIC SCIMED IVUS TECHNOLOGY CENTER, FREMONT, CALIFORNIA FO RINSPECTION FUNCTIONS. |
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