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: S060 · Decision Sep 26, 2018
    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 Endoprosthesis with Heparin Bioactive Surface (AV Access)
    PMA Number
    P130006
    Supplement Number
    S060
    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
    September 26, 2018
    Date Received
    August 27, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Updates to bioburden action/alert limits for the GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface, GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (AV Access) and GORE VIATORR Tips Endoprosthesis, as well as approval to reassess alert limits periodically according to the given protocol and report updated alert limits in future PMA annual reports.

    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