BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P840001 · Supplement: S445 · Decision Oct 23, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55

    Basic Information

    Device Name
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
    Trade Name
    Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu
    PMA Number
    P840001
    Supplement Number
    S445
    Device Class
    FDA Class 3
    Product Code
    LGW
    Generic Name
    Stimulator, spinal-cord, totally implanted for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 23, 2019
    Date Received
    September 23, 2019
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for labeling changes to update existing Notes to Cautions and minor editorial changes for clarification and cross-therapy alignment purposes to the labeling for the; Spinal Cord Stimulation (SCS) Leads 1x8 Family, Injex Anchor Accessory Kits, Intellis Implantable Neurostimulation System for SCS, and SCS Screening Trial Leads.

    Classifications

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

    Product Code Device Name
    LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief