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Device | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S071 |
Date Received | 04/10/2002 |
Decision Date | 05/02/2002 |
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 ROTATIONAL ANGIOPLASTY SYSTEM. THE CHANGE INVOLVES A REDUCTION IN THE NUMBER OF AUDIT SAMPLES TAKEN FOR DESTRUCTIVE PULL TESTING FROM THE LASER SUBASSEMBLY LINE. |