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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 | S059 |
Date Received | 12/06/2000 |
Decision Date | 12/29/2000 |
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 |
Approval Order Statement CHANGE TO THE MANUFACTURING PROCESS FOR THE ROTABLATOR ROTALINK ADVANCER. THE CHANGE WILL INCREASE THE PRESSURE WITH WHICH THE FRONT PLUG IS PRESSED INTO THE TURBINE HOUSING. |