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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceXIENCE ALPINE RX & OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Generic NameCoronary drug-eluting stent
ApplicantABBOTT VASCULAR
3200 Lakeside Drive
Santa Clara, CA 95054
PMA NumberP110019
Supplement NumberS070
Date Received06/04/2014
Decision Date09/03/2014
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
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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