BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Dorsal Root Ganglion Stimulator For Pain Relief

    PMA: P150004 · Supplement: S015 · Decision Oct 13, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Dorsal Root Ganglion Stimulator For Pain Relief
    Trade Name
    DRG Lead Extension Kit
    PMA Number
    P150004
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    PMP
    Generic Name
    Dorsal root ganglion stimulator for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 13, 2017
    Date Received
    September 13, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Changes to the dorsal root ganglion (DRG) lead extension manufacturing process at the St. Jude Medical (SJM) Plano, Texas facility. Specifically, it requested updates to the DRG lead extension socket assembly and header molding processes. These changes only apply to the DRG lead extension header component assembly and molding process.

    Classifications

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

    Product Code Device Name
    PMP Dorsal Root Ganglion Stimulator For Pain Relief