BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dorsal Root Ganglion Stimulator For Pain Relief

    PMA: P150004 · Supplement: S041 · Decision Jan 19, 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
    Proclaim SCS Neurostimulator System
    PMA Number
    P150004
    Supplement Number
    S041
    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
    January 19, 2021
    Date Received
    July 14, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for addition of BurstDR programs with multiple stimsets for Proclaim SCS System, programming enhancements for SCS therapy, cybersecurity enhancements and other minor enhancements for improvement. Approval for cybersecurity enhancements and other minor enhancements for improvement.

    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