BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Electrical Impedance Spectrometer

    PMA: P150046 · Supplement: S001 · Decision Jul 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Electrical Impedance Spectrometer
    Trade Name
    Nevisense
    PMA Number
    P150046
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    ONV
    Generic Name
    Electrical Impedance Spectrometer
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 13, 2018
    Date Received
    May 9, 2018
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for addition of a patient labeling for the Nevisense Device.

    Classifications

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

    Product Code Device Name
    ONV Electrical Impedance Spectrometer