Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ROTATIONAL ANGIOPLASTY SYSTEM WITH ROTALINK PLUS EXCHANGEABLE CATHETER/ADVANCER |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S056 |
Date Received | 09/29/2000 |
Decision Date | 10/24/2000 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ADDITIONAL MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORK LTD., CORK, IRELAND AND AN ADDITIONAL STERILIZATION FACILITY LOCATED AT ISOTRON IRELAND LTD., OFFALY, IRELAND. |
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