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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, XIENCE NANO,XIENCE PRIME, XIENCE PRIME LONG LESION,XIENCE XPEDITION XIENCE XPEDITION SMALL VESSEL AND XPEDITIO
Generic NameCoronary drug-eluting stent
ApplicantABBOTT VASCULAR INC.
26531 YNEZ ROAD, BUILDING G
P.O.BOX 9018
TEMECULA, CA 92589-9018
PMA NumberP070015
Supplement NumberS117
Date Received11/27/2013
Decision Date09/04/2014
Withdrawal Date 04/26/2023
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE POST APPROVAL STUDY LABELING UPDATES FOR THE CLINICAL STUDIES FOLLOWED UNDER THIS PMA FOR THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENTS.
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