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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 INC.
PMA NumberP070015
Supplement NumberS001
Date Received07/16/2008
Decision Date10/01/2009
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to update the instructions of use (ifu) and patient guide with the spirit iii clinical trial 2-year data.
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