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Device | XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM |
Generic Name | Coronary drug-eluting stent |
Applicant | ABBOTT VASCULAR INC. 26531 YNEZ ROAD, BUILDING G P.O.BOX 9018 TEMECULA, CA 92589-9018 |
PMA Number | P070015 |
Supplement Number | S054 |
Date Received | 11/26/2010 |
Decision Date | 05/24/2011 |
Withdrawal Date
|
04/26/2023 |
Product Code |
NIQ |
Docket Number | 11M-0431 |
Notice Date | 06/03/2011 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |