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Device | ROTABLATOR ROTALINK ADVANCER AND ROTALINK PLUS |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S121 |
Date Received | 02/14/2013 |
Decision Date | 05/23/2013 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR USE OF AN ALTERNATE PROCESSING AID IN THE MANUFACTURE OF THE RESIN USED TO MAKE THE INNER PTFE LINER IN THE SLIDE TUBE COMPONENT OF THE ROTALINK ADVANCER. |