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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 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 NumberS050
Date Received10/12/2010
Decision Date11/08/2010
Withdrawal Date 04/26/2023
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
MODIFICATION OF A DEVICE PACKAGING QUALITY CONTROL TEST.
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