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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/MINI VISION/MULTI-LINK 8TM/8TM LL/8TM SV CORONARY STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantABBOTT VASCULAR
P.O. BOX 9018
TEMECULA, CA 92589-9018
PMA NumberP020047
Supplement NumberS030
Date Received03/04/2011
Decision Date03/18/2011
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN RESIN VERIFICATION AT RECEIVING INSPECTION.
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