BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    PMA: P130006 · Supplement: S098 · Decision Jul 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14

    Basic Information

    Device Name
    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
    Trade Name
    GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
    PMA Number
    P130006
    Supplement Number
    S098
    Device Class
    FDA Class 3
    Product Code
    PFV
    Generic Name
    System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 21, 2023
    Date Received
    June 26, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Upgraded manufacturing equipment to be used for an additional endoprosthesis assembly manufacturing line.

    Classifications

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

    Product Code Device Name
    PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment