BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P140009 · Supplement: S116 · Decision Jun 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    Liberta RC Deep Brain Stimulation Implantable Pulse Generator
    PMA Number
    P140009
    Supplement Number
    S116
    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
    June 9, 2025
    Date Received
    March 11, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for 1) qualifying an alternate Gemini implanted pulse generator (IPG) feedthrough supplier, Integer, along with associated design change, in which the alumina in the ceramic portion of the feedthrough is increasing in level of purity; and 2) qualifying an optional Gemini IPG Can buffing step at current IPG Can supplier, National Manufacturing, to remove cosmetic defect marks on the IPG Can.

    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