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

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S186 · Decision Dec 9, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    PARADIGM REAL-TIME SYSTEM,PARADIGM REAL-TIME REVEL SYSTEM
    PMA Number
    P980022
    Supplement Number
    S186
    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 9, 2015
    Date Received
    November 9, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    TO MAKE CHANGES IN THE INCOMING INSPECTION CRITERIA FOR THE BLUE TEST PLUG TO REMOVE THE INSPECTION OF 5 NON-CRITICAL DIMENSIONS. THE BLUE TEST PLUG IS INTENDED FOR USE WITH THE MINILINK TRANSMITTER (MMT-7703) AND IT IS AN ACCESSORY OF PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, AND MINIMED 530G SYSTEMS.

    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