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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
Generic NameCoronary drug-eluting stent
ApplicantABBOTT VASCULAR INC.
26531 YNEZ ROAD, BUILDING G
P.O.BOX 9018
TEMECULA, CA 92589-9018
PMA NumberP070015
Supplement NumberS094
Date Received06/19/2012
Decision Date09/19/2012
Withdrawal Date 04/26/2023
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL TO CHANGE THE COATING INTEGRITY SPECIFICATION FOR THE 28 MM LENGTH STENTS TO ALIGN WITH THAT OF THE 33 MM AND 38 MM STENTS FOR THE XIENCE FAMILY OF PRODUCTS.
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