BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

    PMA: P230023 · Supplement: S006 · Decision May 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions
    Trade Name
    GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE)
    PMA Number
    P230023
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    QZK
    Generic Name
    Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 20, 2025
    Date Received
    November 22, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    use of the Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis as a branch component option for the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE)

    Classifications

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

    Product Code Device Name
    QZK Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions