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Device | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM/ROTALINK PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S101 |
Date Received | 08/17/2010 |
Decision Date | 01/07/2011 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MATERIAL AND VENDOR CHANGE FOR THE INFUSION HOSE OF THE ROTABLATOR ROTALINK PLUS AND ROTALINK ADVANCER AND EXCHANGEABLE CATHETER. |