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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 Vision/ MULTI-LINK Mini Vision Coronary Stent System, MULTI-LINK 8/ 8 SV/ 8 LL Coronary Stent System
Generic NameSTENT, CORONARY
ApplicantAbbott Vascular
P.O. Box 9018
Temecula, CA 92589
PMA NumberP020047
Supplement NumberS069
Date Received06/13/2018
Decision Date07/10/2018
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 the product bioburden sampling plan for coronary stent systems.
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