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

    Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

    PMA: P230023 · Supplement: S007 · Decision Jan 3, 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
    PMA Number
    P230023
    Supplement Number
    S007
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 3, 2025
    Date Received
    January 2, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a change to the manufacturing process for the leading olive component of the delivery system of Gore 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