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Device | ROTABLATOR 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 | S089 |
Date Received | 05/07/2007 |
Decision Date | 10/29/2008 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR 1) A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION, FREMONT, CALIFORNIA; AND 2) THE ADDITION OF A VENDOR FOR CONSOLE ACCESSORIES. |