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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 NANO AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Generic NameCoronary drug-eluting stent
ApplicantABBOTT VASCULAR INC.
26531 YNEZ ROAD, BUILDING G
P.O.BOX 9018
TEMECULA, CA 92589-9018
PMA NumberP070015
Supplement NumberS078
Date Received07/26/2011
Decision Date08/25/2011
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  
FOUR MANUFACTURING PROCESS CHANGES, WHICH HAVE BEEN PREVIOUSLY APPROVED FOR XIENCE V. THE CHANGES INCLUDED: (A) REMOVAL OF INITIAL CLEAN AND PLASMA TREATMENT; (B) REMOVAL OF DRUG FINAL WEIGH; (C) MODIFIED CLEAN ROOM GOWNING; AND (D) MODIFICATIONS TO THE SPRAY COATING PROCESS.
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