BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P190021 · Supplement: S009 · Decision Jun 20, 2025
    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
    S009
    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
    June 20, 2025
    Date Received
    March 25, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for labeling updates for the Mainstay ReActiv8 System including: 1) inclusion of 5-year follow-up clinical data in the “Clinical Summary” manual and 2) updates to risks in the “Implant and Programming” manual and the “User Manual”.

    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