Premarket Approval (PMA)

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.

• Device: XIENCE V AND NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Generic Name: Coronary drug-eluting stent
• Applicant: Abbott Vascular, Inc.; 26531 Ynez Rd., Bldg. G; P.O. Box 9018; Temecula, CA 92589
• PMA Number: P070015
• Supplement Number: S128
• Date Received: 02/02/2015
• Decision Date: 09/23/2015
• Withdrawal Date: 04/26/2023
• Product Code: NIQ
• Docket Number: 15M-3516
• Notice Date: 10/15/2015
• Advisory Committee: Cardiovascular
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

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 Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2