BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

    PMA: P230023 · Supplement: S005 · Decision Nov 18, 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
    Supplement Number
    S005
    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
    November 18, 2024
    Date Received
    October 18, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for a manufacturing site W. L. Gore & Associates, Inc. located at 32360 N. North Valley Pkwy Phoenix AZ, 85085-4228 for manufacture and packaging of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Aortic Component (implant and delivery system).

    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