BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P130022 · Supplement: S044 · Decision Oct 12, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55

    Basic Information

    Device Name
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
    Trade Name
    Senza HFX iQ System, Senza HFX iQ IPG, HFX Trial Stimulator, HFX iQ Remote, HFX iQ Patient Application
    PMA Number
    P130022
    Supplement Number
    S044
    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
    October 12, 2022
    Date Received
    March 2, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a new Implantable Pulse Generator (IPG) system called the Senza HFX iQ system. The Senza HFX iQ system includes the following devices:1) Bluetooth enabled IPG called the HFX iQ IPG (IPG3000);2) Updated Senza Bluetooth Trial Stimulator called the HFX Trial Stimulator (TSM3500);3) Updated compatible Bluetooth Patient Remote called the HFX iQ Remote (PTR3000);4) New mobile device application software called as the HFX iQ Patient Application (PTA); 5) Updated Clinician Programmer software to configure the Bluetooth Trial Stimulators and Bluetooth IPG; and6) New software called as Gaea Cryptofunction that implements certain cybersecurity features of the Senza HFX iQ system.

    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