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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 | S130 |
Date Received | 01/03/2014 |
Decision Date | 01/30/2014 |
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 |
Approval Order Statement CHANGE TO THE LONG DRIVE LASER WELDER EQUIPMENT USED IN THE ROTALINK LONG DRIVE SUB-ASSEMBLY LINE. |