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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.
 
DeviceMulti-Link 8 Coronary Stent System
Generic NameSTENT, CORONARY
ApplicantAbbott Vascular
P.O. Box 9018
Temecula, CA 92589
PMA NumberP020047
Supplement NumberS065
Date Received06/05/2017
Decision Date12/15/2017
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Sterigenics UK Limited, Cotes Park Estate, Somercotes, Derbeyshire DE55 4NJ, United Kingdom, for sterilization of Multi-Link 8 / Multi-Link 8LL / Multi-Link 8SV Coronary Stent System manufactured at Abbott Vascular’s Clonmel, Ireland facility.
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