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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 NANO 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 NumberS107
Date Received04/02/2013
Decision Date09/23/2014
Withdrawal Date04/26/2023
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE PARTICULATE TEST METHOD AND PARTICULATE SPECIFICATION USED FOR THE STABILITY TESTING OF THE XIENCE V AND XIENCE NANO EVEROLIMUS-ELUTING CORONARY STENT SYSTEMS.
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