BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P140009 · Supplement: S005 · Decision Dec 18, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    BRIO LE CHARGING SYSTEM
    PMA Number
    P140009
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    MHY
    Generic Name
    Stimulator, electrical, implanted, for parkinsonian tremor
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 18, 2015
    Date Received
    September 21, 2015
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MEXICO, TIJUANA, BAJA CALIFORNIA, MEXICO.

    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