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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 NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
Generic Namedrug eluting coronary stent system
ApplicantABBOTT VASCULAR
PMA NumberP070015
Supplement NumberS082
Date Received10/20/2011
Decision Date03/13/2012
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for extending the shelf life from 12 months to 24 months for the device.
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