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

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P140009 · Supplement: S016 · Decision Jun 28, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    DEEP BRAIN STIMULATION SYSTEM (LIBRA, LIBRA XP)IPG'S; (LIBRA, BRIO) CLINICIAN PROGRAMMERS
    PMA Number
    P140009
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    MHY
    Generic Name
    Stimulator, electrical, implanted, for parkinsonian tremor
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 28, 2016
    Date Received
    June 13, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change to the material used for the printed circuit board for the Genesic, Eon-C, Libra, and Libra XP Implantable Pulse Generators (IPGs), the Genesis and Eon/Protégé/Prodigy Patient Programmers, and the Libra and Brio Clinician Programmers.

    Classifications

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

    Product Code Device Name
    MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor