BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P190021 · Decision Jun 16, 2020
    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
    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 16, 2020
    Date Received
    August 29, 2019
    Expedited Review
    N
    Docket Number
    20M-1583

    Advisory Committee Statement

    Approval for the ReActiv8 System is indicated for bilateral stimulation of the L2 medial branch of the dorsal ramus as it crosses the transverse process at L3 as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy and are not candidates for spine surgery.

    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