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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 RX MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantAbbott Vascular, Inc.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP970020
Supplement NumberS002
Date Received02/24/1998
Decision Date02/03/1999
Withdrawal Date04/15/2025
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an alternate method of sterilization (Electron Beam) for the ACS RX Multi-Link(TM) HP and the ACS OTW Multi-Link(TM) HP Coronary Stent Systems.
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