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Device | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S122 |
Date Received | 05/21/2013 |
Decision Date | 06/19/2013 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGES TO THE EQUIPMENT USED FOR THE PRESSING, BONDING AND FIBER OPTIC CRIMPING AND TRIMMING OPERATIONS FOR THE ROTALINK ADVANCER AND CATHETER WHICH ARE PART OF THE ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM. |