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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 & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)
Generic NameCoronary drug-eluting stent
ApplicantABBOTT VASCULAR INC.
26531 YNEZ ROAD, BUILDING G
P.O.BOX 9018
TEMECULA, CA 92589-9018
PMA NumberP070015
Supplement NumberS068
Date Received04/11/2011
Decision Date05/12/2011
Withdrawal Date 04/26/2023
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
CHANGES TO THE TEST METHOD FOR THE IDENTIFICATION AND ASSAY OF ANTIOXIDANT IN THE ACCEPTANCE AND STABILITY TESTING OF THE EVEROLIMUS DRUG SUBSTANCE.
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