BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Iliac Covered Stent, Arterial

    PMA: P160021 · Decision Jan 27, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Iliac Covered Stent, Arterial
    Trade Name
    GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
    PMA Number
    P160021
    Device Class
    FDA Class 3
    Product Code
    PRL
    Generic Name
    Iliac covered stent, arterial
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 27, 2017
    Date Received
    July 5, 2016
    Expedited Review
    N
    Docket Number
    16M-0560

    Advisory Committee Statement

    Approval for the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5mm - 13mm and lesion lengths up to 110mm, including lesions at the aortic bifurcation.

    Classifications

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

    Product Code Device Name
    PRL Iliac Covered Stent, Arterial