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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 8 CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent
ApplicantABBOTT VASCULAR
PMA NumberP020047
Supplement NumberS042
Date Received02/06/2012
Decision Date04/03/2012
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the multi-link 8 coronary stent system instructions for use (ifu) to align/update the ifu verbiage with a recently approved coronary stent system.
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