BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P140009 · Supplement: S087 · Decision Jan 24, 2024
    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 DBS IPG ,Charger Kit - Pectoral ,Patient Controller Application ,Clinician Programmer Application
    PMA Number
    P140009
    Supplement Number
    S087
    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
    January 24, 2024
    Date Received
    July 28, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    For P140009/S087, approval for:• The Liberta RCTM DBS System, including the Liberta RC DBS IPG (model 62400) and Charger Kit – Pectoral (model 66000)• Patient Controller Application version 2.0 and Clinician Programmer Application version 2.0 including the NeuroshpereTM Virtual Clinic • Alternate resistor component changes in the printed circuit board assembly (PCBA) for the Liberta RC DBS IPG (model 62400)• An alternate cell battery part number from an existing supplier for Charger Model 16000 when used with the Liberta RC DBS SystemFor P010032/S202, approval for:• Patient Controller Application version 2.0 and Clinician Programmer Application version 2.0 including the NeuroshpereTM Virtual Clinic and FlexBurst360TM programming• Change the requirement regarding MRI mode during charging in the Eterna SCS System to align with the Liberta RC DBS System

    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