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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 AND MULTI-LINK 8 LL CORONARY STENT SYSTEM (CSS)
Classification Namestent, coronary
Generic Namecoronary stent
ApplicantABBOTT VASCULAR
PMA NumberP020047
Supplement NumberS046
Date Received02/22/2012
Decision Date08/20/2012
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a sterilization site located in tipperary. Ireland.
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