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: S006 · Decision Aug 15, 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
    S006
    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
    August 15, 2023
    Date Received
    July 13, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Removal of the spot weld process for Reactiv8 Implantable Neurostimulation System’s Implantable Pulse Generator (IPG) internal battery sleeve at Centro De Construccion De Cardioestimuladores Del Uruguay S.A.

    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