BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P130022 · Supplement: S061 · Decision Jun 30, 2025
    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
    Nevro Corp Senza Spinal Cord Stimulation (SCS) System
    PMA Number
    P130022
    Supplement Number
    S061
    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
    June 30, 2025
    Date Received
    September 3, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for the addition of alternate suppliers to the feedthrough (i.e., Integer Tijuana) and titanium case (i.e., Greatbatch Medical) components of the implantable pulse generator (IPG) used in the Senza SCS System, and approval for minor changes made to the feedthrough to improve manufacturability and yield of this component and additional reference specifications that were added for the titanium case for better manufacturability

    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