BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Superficial Femoral Artery

    PMA: P040037 · Supplement: S050 · Decision Oct 18, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Stent, Superficial Femoral Artery
    Trade Name
    GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE
    PMA Number
    P040037
    Supplement Number
    S050
    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
    October 18, 2013
    Date Received
    April 29, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A 25CM LENGTH FOR THE 5-8MM DIAMETER ENDOPROSTHESES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE AND IS INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN SUPERFICIAL FEMORAL ARTERY LESIONS UP TO 230 MM IN LENGTH WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 7.5 MM. THE GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE ARE ALSO INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN ILIAC ARTERY LESIONS UP TO 80 MM IN LENGTH WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 12 MM.

    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