BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Low Electric Field, Tumor Treatment

    PMA: P100034 · Supplement: S035 · Decision Sep 24, 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 System
    PMA Number
    P100034
    Supplement Number
    S035
    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
    September 24, 2024
    Date Received
    June 26, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval to adjust the capacitance specification for the ceramic discs used in the INE Transducer Arrays. The supplement also proposed to add TDK Electronics GmbH & Co. OG (TDK), located at Siemensstrasse 43, 8530 Deutschlandsberg, Austria, as an additional supplier for the lead-free ceramic discs, so that these components may be sourced from either Vishay Electronics GmbH or TDK

    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