BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Automated Insulin Dosing Device System, Single Hormonal Control

    PMA: P160017 · Supplement: S115 · Decision Jan 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Automated Insulin Dosing Device System, Single Hormonal Control
    Trade Name
    Guardian™ Sensor 3, Guardian™ 4 Sensor
    PMA Number
    P160017
    Supplement Number
    S115
    Device Class
    FDA Class 3
    Product Code
    OZP
    Generic Name
    Automated insulin dosing device system, single hormonal control
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 5, 2024
    Date Received
    December 8, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to increase the allowable maximum sterilization dose for the Guardian Sensor (3) and Guardian 4 Sensor. The Guardian Sensor (3) is a component of the MiniMed 670G, MiniMed 770G, and MiniMed 780G Systems, MiniMed 630G System with Smart Guard, and Guardian Connect Systems. The Guardian 4 Sensor is a component of the MiniMed 780G System

    Classifications

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

    Product Code Device Name
    OZP Automated Insulin Dosing Device System, Single Hormonal Control