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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameACS MULTI-LINK RX TRISTAR/ACS MULTI-LINK OTW TRISTAR
Classification Namestent, coronary
Generic Nameintravascular coronary stent
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP970020
Supplement NumberS022
Date Received04/06/2000
Decision Date05/16/2000
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 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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