BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

    PMA: P190021 · Supplement: S008 · Decision Dec 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief
    Trade Name
    ReActiv8 Implantable Neurostimulation System
    PMA Number
    P190021
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    QLK
    Generic Name
    Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 12, 2024
    Date Received
    November 14, 2024
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for modifications to labeling related to two separate updates, clarification regarding the allowable receive coils compatible with the system’s Magnetic Resonance (MR) conditional labelling and refinement of the considerations for patient selection

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QLK Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief