BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dorsal Root Ganglion Stimulator For Pain Relief

    PMA: P150004 · Supplement: S088 · Decision Sep 26, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Dorsal Root Ganglion Stimulator For Pain Relief
    Trade Name
    Proclaim™ DRG System
    PMA Number
    P150004
    Supplement Number
    S088
    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
    September 26, 2025
    Date Received
    June 30, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval for an alternate second tier supplier of carbon fiber for use in cathode of the battery

    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