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Device | ROTABLATOR SYSTEM/ROTALINK PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S099 |
Date Received | 03/08/2010 |
Decision Date | 08/13/2010 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR: 1) CHANGE FROM IN-HOUSE MOULDING OF FOUR COMPONENTS TO AN OUTSOURCED MOULDING VENDOR; 2) A CHANGE IN THE MOULDING GATE DESIGN AND LOCATION; 3) CHANGE IN MOULDING MACHINE; AND 4) CHANGE IN THE INSPECTION PROCESS FOR THE COMPONENTS. |