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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 AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)
Generic NameCoronary drug-eluting stent
ApplicantAbbott Vascular, Inc.
26531 Ynez Rd., Bldg. G
P.O. Box 9018
Temecula, CA 92589
PMA NumberP070015
Supplement NumberS017
Date Received05/01/2009
Decision Date07/09/2009
Withdrawal Date04/26/2023
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF SEVERAL TEST METHODS FOR AN EXCIPIENT USED IN THE MANUFACTURE OF THE DEVICE.
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