BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S149 · Decision Aug 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    ACTIVA IMPLAMTABLE NEUROSTIMULATORS: ACTIVA RC MODEL 37612, ACTIVA PC MODEL 37601, ACTIVA SC MODEL 37602 AND ACTIVA SC M
    PMA Number
    P960009
    Supplement Number
    S149
    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
    August 24, 2012
    Date Received
    June 22, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ELIMINATING THE EXTERNAL PARYLENE COATING FROM THEFOLLOWING IMPLANTABLE NEUROSTIMULATORS: ACTIVA RC MODEL 37612, ACTIVA PC MODEL 37601, ACTIVA SC MODEL 37602 AND ACTIVA SC MODEL 37603.

    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