BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Low Electric Field, Tumor Treatment

    PMA: P100034 · Supplement: S019 · Decision Dec 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Stimulator, Low Electric Field, Tumor Treatment
    Trade Name
    Optune System
    PMA Number
    P100034
    Supplement Number
    S019
    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
    December 19, 2018
    Date Received
    September 20, 2018
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to Optune System carrying case and INE Transducer Array package sizes; Optune System software modifications increasing the secondary alarm threshold for INE Transducer Array partial attachment, correcting data transfer processing following switch from battery to mains power, and eliminating a redundant INE Transducer Array overheating alarm; and NovoTerminal software modifications improving Optune System data transfer processing.

    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