BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions

    PMA: P250033 · Decision Apr 2, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions
    Trade Name
    NEXUS Aortic Arch Stent Graft System
    PMA Number
    P250033
    Device Class
    FDA Class 3
    Product Code
    SDZ
    Generic Name
    Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 2, 2026
    Date Received
    August 22, 2025
    Expedited Review
    N
    Docket Number
    26M-3730

    Advisory Committee Statement

    for the NEXUS Aortic Arch Stent Graft System. This device is indicated for the endovascular treatment of chronic dissections involving the aortic arch in patients who are at high risk for open surgical repair and 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
    SDZ Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions