BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P010032 · Supplement: S228 · Decision Dec 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55

    Basic Information

    Device Name
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
    Trade Name
    Eterna Spinal Cord Simulation Implantable Pulse Generator (IPG) and NeuroSphere Digital Health App
    PMA Number
    P010032
    Supplement Number
    S228
    Device Class
    FDA Class 3
    Product Code
    LGW
    Generic Name
    Stimulator, spinal-cord, totally implanted for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 20, 2024
    Date Received
    October 15, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for updating the NeuroSphereTM Clinical Programmer (CP) and NeuroSphereTM Patient Controller (PC) applications from version 2.0.2 to version 2.0.3 and the NeuroSphereTM Digital Health App (OneApp) from version 4.0 to version 4.0.1.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief