BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P190002 · Supplement: S018 · Decision Dec 19, 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
    S018
    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 19, 2023
    Date Received
    September 22, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    This supplement requested approval for extending the labeled shelf life of the following components of Saluda Medical Evoke ® SCS System from one year to two years: CAP12X Lead Extension Kit, Tunnler, and Epidural Needle 6.5”. Additionally, the sponsor requested approval for removal of the labeling disclaimer related to the biocompatibility uncertainty, which reads, "although FDA has determined that the probable benefits outweigh the probable risks, there remains some uncertainty on the long term systemic toxicity risks of the leads, lead extensions, and anchors of the device. As a condition of approval, FDA is requiring the manufacturer to provide additional long term systemic toxicity information. "

    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