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

    Sensor, Glucose, Invasive

    PMA: P160007 · Supplement: S039 · Decision Dec 1, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    Guardian Connect system
    PMA Number
    P160007
    Supplement Number
    S039
    Device Class
    FDA Class 3
    Product Code
    MDS
    Generic Name
    Sensor, glucose, invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 1, 2020
    Date Received
    November 3, 2020
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Manufacturing changes related to bioburden testing for the Enlite Sensor and Guardian Sensor (3). The Enlite Sensor is component of the MiniMed 530G System, the MiniMed 630G System, the Paradigm Real-Time Revel System, and the iPro2 CGM System. The Guardian Sensor (3) is component of the MiniMed 670G System, the Guardian Connect System, and the MiniMed 630G System with SmartGuard.

    Classifications

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

    Product Code Device Name
    MDS Sensor, Glucose, Invasive