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

    Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions

    PMA: P250033 · Supplement: S001 · Decision May 20, 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
    Supplement Number
    S001
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 20, 2026
    Date Received
    April 23, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    implementation of a new clean room and associated controlled areas for manufacturing of the Nexus Aortic Arch Stent Graft System

    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