BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Low Electric Field, Tumor Treatment

    PMA: P100034 · Supplement: S032 · Decision Feb 2, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Stimulator, Low Electric Field, Tumor Treatment
    Trade Name
    Optune
    PMA Number
    P100034
    Supplement Number
    S032
    Device Class
    FDA Class 3
    Product Code
    NZK
    Generic Name
    Stimulator, low electric field, tumor treatment
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 2, 2024
    Date Received
    July 25, 2023
    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 located at United States (U.S.) Operation Center II (USOC II), Novocure Inc., 2555 USA Parkway, Suite 104A, Sparks, Nevada 89437, that will perform the activities of receipt, cleaning, acceptance, storage, service, packaging, labeling and release for distribution of the Optune treatment kit.

    Classifications

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

    Product Code Device Name
    NZK Stimulator, Low Electric Field, Tumor Treatment