BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

    PMA: P230042 · Supplement: S001 · Decision Aug 12, 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
    S001
    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
    Approved
    Decision Code
    APPR
    Decision Date
    August 12, 2025
    Date Received
    May 16, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Sponsor requested approval for replacing the material used for the ITE Transducer Array’s liner component with an equivalent polyethylene terephthalate (PET) material.

    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