BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Coronary Drug-Eluting Stent

    PMA: P070015 · Supplement: S054 · Decision May 24, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32

    Basic Information

    Device Name
    Coronary Drug-Eluting Stent
    Trade Name
    XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM
    PMA Number
    P070015
    Supplement Number
    S054
    Device Class
    FDA Class 3
    Product Code
    NIQ
    Generic Name
    Coronary drug-eluting stent
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 24, 2011
    Date Received
    November 26, 2010
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    11M-0431

    Advisory Committee 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.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NIQ Coronary Drug-Eluting Stent