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

    Stimulator, Low Electric Field, Tumor Treatment

    PMA: P100034 · Supplement: S017 · Decision Mar 15, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Stimulator, Low Electric Field, Tumor Treatment
    Trade Name
    Novocure Ltd.'s Optune
    PMA Number
    P100034
    Supplement Number
    S017
    Device Class
    FDA Class 3
    Product Code
    NZK
    Generic Name
    Stimulator, low electric field, tumor treatment
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 15, 2017
    Date Received
    February 13, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of two second source component suppliers related to the INE transducer array subassembly as well as automation of a related soldering procedure.

    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