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Device | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (ROTABLATOR CONSOLE AND FOOT PEDAL) |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S132 |
Date Received | 02/03/2014 |
Decision Date | 08/01/2014 |
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 COMPONENT AND MANUFACTURING PROCESS CHANGES TO THE ROTABLATOR CONSOLE AND DYNAGLIDE FOOT PEDAL. |