BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

    PMA: P230023 · Decision Jan 12, 2024
    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
    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
    January 12, 2024
    Date Received
    July 19, 2023
    Expedited Review
    N
    Docket Number
    24M-0525

    Advisory Committee Statement

    Approval for the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis. This device is indicated for endovascular repair in patients with thoracoabdominal aortic aneurysms and high-surgical risk patients with pararenal aortic aneurysms who have appropriate anatomy.

    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