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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 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 NumberS054
Date Received11/26/2010
Decision Date05/24/2011
Withdrawal Date04/26/2023
Product Code NIQ 
Docket Number 11M-0431
Notice Date 06/03/2011
Advisory Committee Cardiovascular
Clinical TrialsNCT00180310
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO EXPAND THE PRODUCT MATRIX TO INCLUDE THE 2.25 MM XIENCE V EVEROLIMUS ELUTING CORONARY STEM SYSTEM. THIS DEVICE SIZE WILL BE MARKETED UNDER THE TRADE NAME XIENCE NANO EVEROLIMUS ELUTING CORONARY STEM SYSTEM AND WILL ALSO BE DISTRIBUTED AS THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THE ADDITION OF THE 2.25 MM XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM WILL EXPAND THE ORIGINALLY APPROVED INDICATIONS TO INCLUDE TREATMENT OF CORONARY ARTERY LESIONS WITH REFERENCE VESSEL DIAMETERS >2.25 MM TO <2.50 MM. THEREFORE, THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS NOW INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER INPATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH < 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.25 MM TO 4.25 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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