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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 DUET & ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantAbbott Vascular, Inc.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP970020
Supplement NumberS011
Date Received02/26/1999
Decision Date05/06/1999
Withdrawal Date04/15/2025
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a 5-year post-approval study protocol for the ACS MULTI-LINK RX and OTW DUET(TM) Coronary Stent Systems.
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