BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P010032 · Supplement: S118 · Decision Nov 28, 2016
    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
    SPINAL CORD STIMULATION (SCS) EXTERNAL PROGRAMMER APPS
    PMA Number
    P010032
    Supplement Number
    S118
    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
    November 28, 2016
    Date Received
    June 6, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Clinician Programmer App (Version 3.3) Model 3874 and Programmer App (Version 3.3) Model 3875, and the Proclaim DRG Neurostimulation System which includes the following components:3664 Proclaim DRG IPG7108 Port PlugMN15000 Tunneling Tool KitNot applicable Torque WrenchNot applicable Pocket SizerMN10450-50 Implant Lead Kit, 50cmMN10450-50A Implant Lead Kit, SlimTip, 50cmNot applicable Soft Tissue AnchorMN12050 Lead Accessory Kit3874 St. Jude Medical Clinician Programmer App3875 St. Jude Medical Patient Controller App

    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