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 | ACS MULTI-LINK RX TRISTAR/ACS MULTI-LINK OTW TRISTAR |
Generic Name | STENT, CORONARY |
Applicant | ABBOTT VASCULAR INC. 26531 YNEZ ROAD TEMECULA, CA 92591 |
PMA Number | P970020 |
Supplement Number | S022 |
Date Received | 04/06/2000 |
Decision Date | 05/16/2000 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternate manufacturing facility located at Guidant Corporation, Guidant Ireland located in County Tipperary, Ireland, and an alternate sterilization facility located in Oxfordshire, United Kingdom. |
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