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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 V EVEROLIMUS ELUTING CORONARY STENT SYSTEM ; XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Applicant
ABBOTT VASCULAR
3200 lakeside drive
santa clara, CA 95054
PMA NumberP110019
Supplement NumberS053
Date Received08/30/2013
Decision Date02/28/2014
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR AN UPDATE TO THE LABELING TO REFLECT THE THREE YEAR POST APPROVAL STUDY FINDINGS FROM THE SPIRIT PRIME CLINICAL TRIAL.
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