BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S397 · Decision May 7, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    Medtronic Deep Brain Stimulation Therapy System
    PMA Number
    P960009
    Supplement Number
    S397
    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
    May 7, 2021
    Date Received
    February 23, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for software changes to the Medtronic Model A620 Patient Programmer Application (PPA)which consist of 1) fixing a defect that prevents the software from communicating with certain Model B35200 INSs that have Tel-M IDs containing particular values, 2) updating the impedance test that is used to support the MRI eligibility feature of the A620 PPA, and 3) other minor changes and bug fixes.

    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