BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P190002 · Supplement: S027 · Decision May 16, 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
    Alternative Active Anchor (part number 104504)
    PMA Number
    P190002
    Supplement Number
    S027
    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 16, 2024
    Date Received
    February 16, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the alternative active anchor (part number 104504) which includes the following modifications 1) the curvature of the clamping surface of the bottom clamp plate changed from 0.9mm to 0.66m, and a 0.4mm chamfer was added to the lead edge to facilitate lead insertion, 2) the curved clamping surface of the top clamp plate was removed so that the clamping surface is flat, and 3) the silicone sleeve was removed from within the clamping surfaces.

    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