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

    Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

    PMA: P230042 · Supplement: S004 · Decision Oct 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
    Trade Name
    Optune Lua®
    PMA Number
    P230042
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    SDA
    Generic Name
    Electrical tumor treatment fields for non-small cell lung cancer
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 8, 2025
    Date Received
    September 11, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    introduction of a 15 array/box packaging configuration and a 5 array/box packaging configuration, in addition to the currently approved 20 array/box configuration, for the ITE arrays at Novocure’s contract manufacturer Integra

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SDA Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer