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: S023 · Decision Aug 4, 2015
    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,GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
    PMA Number
    P130006
    Supplement Number
    S023
    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
    August 4, 2015
    Date Received
    July 6, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF A SUPPLIER PROCESS CHANGE TO THE TEMPERATURE SETTING OF THE CURING OVEN USED IN THE MANUFACTURING PROCESS OF A CATHETER COMPONENT.

    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