BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P840001 · Supplement: S512 · Decision Apr 24, 2024
    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
    Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int
    PMA Number
    P840001
    Supplement Number
    S512
    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
    April 24, 2024
    Date Received
    March 1, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for the Pain RC SCS System including: 1) the new Inceptiv LT (Model 977117), Intellis Pro (Model 977118), and Inceptiv (Model 977119) implantable neurostimulators; 2) the Neuro Sense closed-loop stimulation feature for Medtronic Vectris SureScan MRI 1x8 Compact Leads (Models 977A260, 977A275, and 977A290 only); 3) updated Differential Target Multiplexed (DTM) SCS user interface (i.e., the DTM programming style, Spine Anatomy View, and DTM templating feature); and 4) a new wireless recharger (Model WR9230).

    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