BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S142 · Decision Apr 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    37751 RECHARGE CHARGING SYSTEM
    PMA Number
    P960009
    Supplement Number
    S142
    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
    April 20, 2012
    Date Received
    April 4, 2012
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES TO THE MANUALS FOR THE MODEL 37751 RECHARGE CHARGER SYSTEM, THE INFORMATION FOR PRESCRIBERS MANUAL - MEDTRONIC DBS THERAPY, AND THE INFORMATION FOR PRESCRIBERS MANUAL- MEDTRONIC PAIN THERAPY USING NEUROSTIMULATION FOR CHRONIC PAIN. THESE CHANGES INCLUDE THE ADDITION OF PRECAUTIONS RELATED TO RECHARGER USE, MODIFICATION OF THE DEVICE, AND THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON TELEMETRY COMMUNICATION.

    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