BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Superficial Femoral Artery

    PMA: P040037 · Decision Jun 14, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Stent, Superficial Femoral Artery
    Trade Name
    VIABAHN ENDOPROSTHESIS
    PMA Number
    P040037
    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
    June 14, 2005
    Date Received
    August 27, 2004
    Expedited Review
    N
    Docket Number
    05M-0379

    Advisory Committee Statement

    APPROVAL FOR THE GORE VIABAHN ENDOPROSTHESIS. THE DEVICE IS INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN SUPERFICIAL FEMORAL ARTERY LESIONS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.8 TO 7.5 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