BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Low Electric Field, Tumor Treatment

    PMA: P100034 · Supplement: S012 · Decision Mar 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Stimulator, Low Electric Field, Tumor Treatment
    Trade Name
    NOVOTTF-100A SYSTEM
    PMA Number
    P100034
    Supplement Number
    S012
    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
    March 23, 2015
    Date Received
    September 24, 2014
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ADDITIONAL SUPPLIER FOR THE CONVERTER.

    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