BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P010032 · Supplement: S200 · Decision Oct 5, 2023
    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 SCS System
    PMA Number
    P010032
    Supplement Number
    S200
    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
    October 5, 2023
    Date Received
    July 7, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for software update (from 1.0 to 1.1) of the CP and PC Apps. These apps are used by the clinician and patient, respectively, to program or control the Eterna SCS neurostimulation system. The proposed minor design change will update the CP and PC software to address the incorrect formula assumption and display a battery message after the device is past the current lifetime as defined in the product requirement. This change is being made to address field complaints regarding the PC generating premature ERI messages soon after implant.

    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