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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/OTW ULTRA CORONARY STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantAbbott Vascular, Inc.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP970020
Supplement NumberS032
Date Received04/26/2001
Decision Date05/24/2001
Withdrawal Date04/15/2025
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE MANUFACTURING PROCESS FOR STENT PRODUCTION.
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