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

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

    PMA: P190021 · Supplement: S004 · Decision Feb 16, 2023
    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
    S004
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 16, 2023
    Date Received
    January 19, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Qualification of a commercially-available, equivalent programmer laptop for the ReActiv8 Implantable Neurostimulation System.

    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