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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 XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, OTW PLATFORM
Generic NameCoronary drug-eluting stent
ApplicantAbbott Vascular
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP110019
Supplement NumberS061
Date Received01/13/2014
Decision Date03/26/2014
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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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