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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 V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
Generic Namedrug eluting coronary stent system
ApplicantABBOTT VASCULAR
PMA NumberP070015
Supplement NumberS036
Date Received04/29/2010
Decision Date05/23/2011
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Clinical Trials NCT00180310
NCT00180453
NCT00180479
NCT00307047
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for updates to your labeling to include 1-year results from the spirit iv trial, a pooled spirit ii-iii-iv analysis, gender-specific analyses, and updated results from the spirit first, ii, and iii trials.
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