BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dorsal Root Ganglion Stimulator For Pain Relief

    PMA: P150004 · Supplement: S044 · Decision Jun 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Dorsal Root Ganglion Stimulator For Pain Relief
    Trade Name
    NextGen DRG Lead Kit and Accessories
    PMA Number
    P150004
    Supplement Number
    S044
    Device Class
    FDA Class 3
    Product Code
    PMP
    Generic Name
    Dorsal root ganglion stimulator for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 22, 2021
    Date Received
    December 28, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for design changes to the delivery sheath and tunneling tool, including a new material and locking mechanism for the delivery sheath and a new handle and tip design for the tunneling tool, changes to the packaging configurations of the lead kit and accessories kit, and minor labeling changes to reflect the design and packaging changes. This supplement also requested approval for the addition of Microlumen, Inc. as the new supplier of the delivery sheath, Spectra Medical Inc. as the new supplier of the tunneling tool, and Xylem Company as an alternate supplier for the straight stylet.

    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