BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Superficial Femoral Artery

    PMA: P040037 · Supplement: S074 · Decision Jan 8, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Stent, Superficial Femoral Artery
    Trade Name
    GORE VIABAHN ENDOPROSTHESIS
    PMA Number
    P040037
    Supplement Number
    S074
    Device Class
    FDA Class 3
    Product Code
    NIP
    Generic Name
    STENT, SUPERFICIAL FEMORAL ARTERY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 8, 2015
    Date Received
    October 14, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A 7.5 CM ENDOPROSTHESIS LENGTH IN 5-8 MM AND 9 MM DIAMETER CONFIGURATIONS, WITH AND WITHOUT HEPARIN, ON BOTH THE 0.035 GUIDEWIRE CATHETER (75CM AND 120CM LENGTH) AND THE 0.014/0.018 GUIDEWIRE CATHETER (120CM LENGTH).

    Classifications

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

    Product Code Device Name
    NIP Stent, Superficial Femoral Artery