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: S006 · Decision Jul 2, 2014
    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
    PMA Number
    P130006
    Supplement Number
    S006
    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 2, 2014
    Date Received
    June 4, 2014
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF FOURIER TRANSFORM INFRARED SPECTROSCOPY, BACTERIALENDOTOXIN TESTING, HEAVY METALS AS LEAD (HMAL) AND NON-VOLATILE RESIDUE (NVR) TESTING IN THE EAST COAST TESTING CENTER.

    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