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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 ALPINE RX & OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Classification Namecoronary drug-eluting stent
ApplicantABBOTT VASCULAR
PMA NumberP110019
Supplement NumberS070
Date Received06/05/2014
Decision Date09/03/2014
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to change the distal balloon shaft, distal outer member and proximal hypotube components for the xience xpedition everolimus eluting coronary stent system. You indicated that upon implementation of these changes, the new name for the coronary stent system will be the xience alpine¿ everolimus eluting coronary stent system.
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