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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMULTI-LINK VISION & MULTI-LINK MINI VISION CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent
ApplicantABBOTT VASCULAR
PMA NumberP020047
Supplement NumberS007
Date Received12/12/2006
Decision Date02/09/2007
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor modifications to the w-crest portion of both multi-link vision stent systems as well as a non-linear link shift to the medium design multi-link vision coronary stent system.
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