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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 | S061 |
Date Received | 03/16/2001 |
Decision Date | 04/13/2001 |
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 IN THE VENDOR FOR WATER FOR INJECTION (WFI) WHICH IS A COMPONENT OF THE ROTAGLIDE(TM) LUBRICANT AND IS USED IN THE ROTABLATOR SYSTEM. FRESENIUS KABI WILL PRODUCE WFI AT THEIR FACILITY IN ACCORDANCE WITH USP SPECIFICATIONS. |