BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S036 · Decision Mar 2, 2006
    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 DEEP BRAIN STIMULATION (DBS) SYSTEMS MODELS 3387S, 3389S DBS LEADS
    PMA Number
    P960009
    Supplement Number
    S036
    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
    March 2, 2006
    Date Received
    December 28, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE MODEL 3387/3398 DBS LEAD KIT INTENDED FOR USE WITH THE MEDTRONIC IMPLANTABLE SYSTEMS FOR DBS. THE MODIFICATIONS SPECIFIED WERE: TO REMOVE THE PERCUTANEOUS EXTENSION, TO ADD A LEAD CAP, AND TO BUNDLE THE MEDTRONIC IMAGE-GUIDED NEUROLOGICS STIMLOC KIT (BURR HOLE COVER ASSEMBLY) WITH THE DBS LEAD KIT.

    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