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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
Generic NameCoronary drug-eluting stent
ApplicantAbbott Vascular, Inc.
26531 Ynez Rd., Bldg. G
P.O. Box 9018
Temecula, CA 92589
PMA NumberP070015
Supplement NumberS001
Date Received07/16/2008
Decision Date10/01/2009
Withdrawal Date04/26/2023
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO UPDATE THE INSTRUCTIONS OF USE (IFU) AND PATIENT GUIDE WITH THE SPIRIT III CLINICAL TRIAL 2-YEAR DATA.
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