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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 (TM)/ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantAbbott Vascular, Inc.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP970020
Supplement NumberS024
Date Received05/30/2000
Decision Date06/23/2000
Withdrawal Date04/15/2025
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR INCLUSION OF THE SIX-MONTH CLINICAL TRIAL DATA FROM THE DUET STUDY IN THE INSTRUCTIONS FOR USE (IFU) FOR THE ACS MULTI-LINK RX AND OTW DUET(TM) CORONARY STENT SYSTEMS.
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