BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P190002 · Supplement: S034 · Decision Jan 14, 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
    Saluda Medical Evoke SCS System
    PMA Number
    P190002
    Supplement Number
    S034
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 14, 2025
    Date Received
    December 16, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to update the bioburden alert and action limits to align with historical data for the Evoke CAP12 Percutaneous Lead and Trial Lead Kits, Evoke Spares Kit, Evoke Active Anchor Kit, Evoke Active Anchor Kit – L, Evoke CAP12X Lead Extension Kit – 55cm, Evoke Intraoperative Cable, Evoke Epidural Needle and Evoke Tunneler

    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