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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 PRIME/LL, XPEDITION, XPEDITION SV,LL, AND ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantAbbott Vascular
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP110019
Supplement NumberS075
Date Received02/02/2015
Decision Date09/23/2015
Product Code NIQ 
Docket Number 15M-3516
Notice Date 10/15/2015
Advisory Committee Cardiovascular
Clinical TrialsNCT00307047
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 FOR THE XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION, XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THESE DEVICES ARE INDICATED FOR THE FOLLOWING:XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, 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. ADDITIONALLY, THE XIENCE V STENT IS INDICATED FOR TREATING DE NOVO CHRONIC TOTAL CORONARY OCCLUSIONS.XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THE XIENCE PRIME STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY ARTERY LUMINAL DIAMETER IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 32 MM) WITH REFERENCE VESSEL DIAMETERS OF >=2.25 MM TO <= 4.25 MM.ADDITIONALLY, THE XIENCE PRIME STENT SYSTEM IS INDICATED FOR TREATING DE NOVO CHRONIC TOTAL CORONARY OCCLUSIONS. XIENCE XPEDITION, XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM.THE XIENCE XPEDITION STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY ARTERY LUMINAL DIAMETER IN PATIENTS, INCLUDING THOSE WITH DIABETES MELLITUS, WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 32MM) WITH REFERENCE VESSEL DIAMETERS OF >= 2.25 MM TO <= 4.25 MM. IN ADDITION, THE XIENCE XPEDITION STENT SYSTEM IS INDICATED FOR TREATING DE NOVO CHRONIC TOTAL CORONARY OCCLUSIONS. FOR ADDITIONAL INFORMATION PLEASE REFER TO THE APPROVAL ORDER.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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