BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Decision Jul 31, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
    PMA Number
    P960009
    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
    July 31, 1997
    Date Received
    May 1, 1996
    Expedited Review
    Y
    Docket Number
    98M-0905

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC(R) ACTIVA(TM) TREMOR CONTROL SYSTEM WHICH INCLUDES THE MODEL 3387 DBS(TM) LEAD, MODEL 7495 EXTENSION, MODEL 7424 IMPLANTABLE PULSE GENERATOR (IPG), MODEL 7458 MEMORY MODULE, MODEL 7432 CONSOLE PROGRAMMER, BUR HOLE RING AND CAP, MODEL 7452 MAGNET, MODEL 3625 TEST STIMULATOR (SCREENER) AND MODEL 3353/3354 LEAD FRAME KITS AND ACCESSORIES. THIS DEVIC IS INDICATED FOR UNILATERAL THALAMIC STIMULATION FOR THE SUPPRESSION OF TREMOR IN THE UPPER EXTREMITY IN PATIENTS WHO ARE DIAGNOSED WITH ESSENTIAL TREMOR OR PARKINSONIAN TREMOR NOT ADEQUATELY CONTROLLED BY MEDICATIONS AND WHERE THE TREMOR CONSTITUTES A SIGNIFICANT FUNCTIONAL DISABILITY.

    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