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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 CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Namecoronary stent
ApplicantABBOTT VASCULAR
PMA NumberP020047
Supplement NumberS041
Date Received02/01/2012
Decision Date05/25/2012
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 No
Approval Order Statement 
Approval of a sterilization site located at synergy health ireland, ltd. , in offaly, ireland.
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