BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P130022 · Supplement: S067 · Decision Aug 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
    Trade Name
    Senza® HFX iQ™ System
    PMA Number
    P130022
    Supplement Number
    S067
    Device Class
    FDA Class 3
    Product Code
    LGW
    Generic Name
    Stimulator, spinal-cord, totally implanted for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 15, 2025
    Date Received
    December 20, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the printed circuit board assembly (PCBA) board used in IPG3000, including replacing the microcontroller from rev 2 to rev 3, replacing the fuel gauge with a battery voltage measurement circuit, changing the material of the printed circuit board (PCB), moving the PCBA battery fuse from the negative terminal to the positive terminal, other minor modifications to PCB layout (reorganizing components and modification of solder pad size), as well as an alternate PCBA supplier for IPG3000.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief