BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dorsal Root Ganglion Stimulator For Pain Relief

    PMA: P150004 · Supplement: S079 · Decision Jan 13, 2025
    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™ Dorsal Root Ganglion (DRG) IPG
    PMA Number
    P150004
    Supplement Number
    S079
    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 13, 2025
    Date Received
    October 15, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for firmware version 1.3 and OneApp version 4.1, which include an expanded impedance range and updated trim values used for Magnetic Resonance Imaging (MRI) Mode, updated Elective Replacement Indicator requirement for Orion IPG systems, and labeling updates to account for these changes. You are also proposing to add a check for the MR conditional status of the combination of leads and Implanted Pulse Generators before entering MRI Mode, specify spinal cord stimulation therapy type for two MR Conditional leads (Models 3292 & 3219), define six legacy leads in the OneApp code, and add a program validation check during a Virtual Clinic session to OneApp

    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