BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P190002 · Supplement: S014 · Decision Sep 22, 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
    S014
    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
    September 22, 2023
    Date Received
    September 30, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a labeling change to the following implantable components of the Saluda Evoke Spinal Cord Stimulation (SCS) System as Magnetic Resonance (MR) Conditional for head and extremities (1.5 or 3.0 T) and full body (1.5 T):1) Evoke Closed Loop Stimulator Kit;2) Evoke CAP12 Percutaneous Leads Kit – 60/90cm;3) Evoke 12C Percutaneous Leads Kit – 60/90cm;4) Evoke Spares Kit;5) Evoke Active Anchor Kit; and6) Evoke CAP12X Lead Extension Kit – 55cm.

    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