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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceACS MULTI-LINK RX TRISTAR/ACS MULTI-LINK OTW TRISTAR
Generic NameSTENT, CORONARY
ApplicantABBOTT VASCULAR INC.
26531 YNEZ ROAD
TEMECULA, CA 92591
PMA NumberP970020
Supplement NumberS022
Date Received04/06/2000
Decision Date05/16/2000
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
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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