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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.
 
DeviceVISION AND MINVISION CORONARY STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantABBOTT VASCULAR
P.O. BOX 9018
TEMECULA, CA 92589-9018
PMA NumberP020047
Supplement NumberS037
Date Received07/18/2011
Decision Date08/10/2011
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 TO A COMPONENT IN-PROCESS INSPECTION
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