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

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S184 · Decision Dec 4, 2015
    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; PARADIGM REAL-TIME REVEL INSULIN PUMP
    PMA Number
    P980022
    Supplement Number
    S184
    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 4, 2015
    Date Received
    November 4, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE FROM A MANUAL TO AUTOMATED PROCESS OF ASSEMBLING THE MOTOR GEARBOX OF THE PARADIGM REAL-TIME INSULIN PUMP AND PARADIGM REAL-TIME REVEL INSULIN PUMP. THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL SYSTEMS, RESPECTIVELY.

    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