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Device | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK EXCHANGABLE CATHETER |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S094 |
Date Received | 09/09/2008 |
Decision Date | 01/14/2009 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING CHANGE TO THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ¿ ROTALINK EXCHANGEABLE CATHETER, WHICH REVISES THE RECOMMENDED OPTIMAL ROTATIONAL SPEED RANGE FOR THE SYSTEM. |