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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 NameXIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)
Classification Namecoronary drug-eluting stent
ApplicantABBOTT VASCULAR
PMA NumberP110019
Supplement NumberS023
Date Received06/07/2012
Decision Date08/06/2012
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for updating labeling for the xience prime everolimus eluting coronary stent system to reflect a 24 month shelf life.
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