BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S026 · Decision Oct 31, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    MEDTRONIC MODEL 7482 DBS EXTENSION
    PMA Number
    P960009
    Supplement Number
    S026
    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
    October 31, 2002
    Date Received
    July 15, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES TO THE APPROVED MODEL 7482 DBS EXTENSION; COMBINE LOW PROFILE DESIGN AND TECHNOLOGY WITH A LOW IMPEDANCE CONDUCTOR, CHANGE THE COATING USED ON THE OUTSIDE DIAMETER TO SILOXANE, ADD A NEW TORQUE WRENCH TO THE EXTENSION PACKAGE, AND ADD A NEW MODEL 3550-25 BOOTS ACCESSORY 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