BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dorsal Root Ganglion Stimulator For Pain Relief

    PMA: P150004 · Supplement: S045 · Decision Jul 2, 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
    Dorsal Root Ganglion (DRG) Stimulation System
    PMA Number
    P150004
    Supplement Number
    S045
    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
    July 2, 2021
    Date Received
    March 10, 2021
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a cleaning process change that replaces the Trichloroethylene (TCE) cleaning agent, used in the first ultrasonic cleaning step to clean Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion (DRG) needles, with CleanSafe-501ESF (CS-501ESF).

    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