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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 8TM/MULTI-LINK 8 LLTM/MULTI-LINK 8TM SV CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent
ApplicantABBOTT VASCULAR
PMA NumberP020047
Supplement NumberS023
Date Received09/16/2010
Decision Date02/03/2011
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) the addition of sensors for monitoring the coating process; and 2) minor tooling upgrades.
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