BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P190002 · Supplement: S012 · Decision May 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
    Saluda Medical Evoke SCS System
    PMA Number
    P190002
    Supplement Number
    S012
    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
    May 5, 2023
    Date Received
    May 16, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes which include:1) Modification of the implanted pulse generator (IPG) without changes to delivered therapy;2) Modification of the external Closed-Loop Stimulator (eCLS) to be consistent with the new IPG features and to replace obsolete components;3) Firmware and Software changes to: a. Simplify use of Clinical Software, b. Improve usability and user interface during programming, and c. Improve traceability.4) Change from Surface Pro 4 to Surface Pro 6 as hardware platform for the Clinical Interface due to obsolescence; and5) Minor labelling updates to reflect the proposed changes to the IPG, firmware, and software.

    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