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 | BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDE WIRES GOLD PLATING PROCESS/FLOPPY GOLD |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S068 |
Date Received | 02/05/2002 |
Decision Date | 02/21/2002 |
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 A MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC CORPORATION, MIAMI TECHNOLOGY CENTER, MIAMI, FLORIDA. THE FLOPPY GOLD GUIDE WIRE GOLD PLATING PROCESS WILL BE PERFORMED AT THIS FACILITY. |
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