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Device | ROTABLATOR(R) ROTALINK EXCHANGEABLE CATHETER |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S058 |
Date Received | 11/17/2000 |
Decision Date | 12/12/2000 |
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 CHANGE TO THE MANUFACTURING PROCESS FOR THE ROTABLATOR ROTALINK EXCHANGEABLE CATHETER TO INCREASE THE MAXIMUM ALLOWED ENERGY USED DURING THE LASER WELD PROCESS ON THE CATHETER DRIVE ASSEMBLY HANDSHAKE. |