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

    Automated Insulin Dosing , Threshold Suspend

    PMA: P150001 · Supplement: S098 · Decision Apr 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Automated Insulin Dosing , Threshold Suspend
    Trade Name
    Guardian Sensor (3) (MMT-7020), Enlite Sensor (MMT-7008)
    PMA Number
    P150001
    Supplement Number
    S098
    Device Class
    FDA Class 3
    Product Code
    OZO
    Generic Name
    Automated insulin dosing , threshold suspend
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 29, 2022
    Date Received
    April 1, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of an alternate bioburden and sterility contract testing laboratory for the Enlite sensor and the Guardian Sensor (3). The Enlite sensor is a components of the MiniMed 530G, 630G, Paradigm Real-Time Revel, and iPro2 CGM systems. The Guardian Sensor (3) is a component of the MiniMed 630G, Guardian Connect, 670G and 770G systems.

    Classifications

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

    Product Code Device Name
    OZO Automated Insulin Dosing , Threshold Suspend