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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 XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, OTW PLATFORM
Classification Namecoronary drug-eluting stent
ApplicantABBOTT VASCULAR
PMA NumberP110019
Supplement NumberS061
Date Received01/13/2014
Decision Date03/26/2014
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a labeling change for the xience xpedition, xience xpedition sv, and the xience xpedition ll everolimus eluting coronary stent system for the otw platform. This labeling change requested a shelf life extension from 24 to 36 months.
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