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

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S199 · Decision May 10, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    Paradigm Real-Time Insulin Pump & Paradign Real-Time Revel Insulin Pump
    PMA Number
    P980022
    Supplement Number
    S199
    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
    May 10, 2017
    Date Received
    April 10, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Transfer equipment used for leak testing seals of the Paradigm insulin infusion pumps and Next Generation insulin infusion pumps from Medtronic MiniMed to a sub-tier supplier, as well as transferring the task of performing such testing to the sub-tier supplier. The Paradigm insulin infusion pump is component of the Paradigm REAL-Time System, the Paradigm REAL-Time Revel System, and the MiniMed 530G System. The Next Generation insulin infusion pump is a component of the MiniMed 630G System and the MiniMed 670G System.

    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