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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 CORONARY STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantAbbott Vascular, Inc.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP970020
Supplement NumberS006
Date Received10/19/1998
Decision Date11/10/1998
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  
The 30-day Notice requested that FDA review a change in the manufacturing process, removing the C-flex Junction Shear Strength Test, a design verification test, from production testing of the ACS RX MULTI-LINK(TM) Coronary Stent System and the ACS RX MULTI-LINK HP(TM) Coronary Stent System.
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