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

    Sensor, Glucose, Invasive

    PMA: P150019 · Supplement: S036 · Decision Feb 28, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    Paradigm Real Time Revel Insulin Pump
    PMA Number
    P150019
    Supplement Number
    S036
    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
    February 28, 2018
    Date Received
    January 29, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change of O-ring supplier for MiniMed 630G, 670G, and Paradigm REAL-Time family of insulin pumps, which are components of the MiniMed 670G System, MiniMed 630G System with SmartGuard, MiniMed Paradigm Real-Time Revel System with Enlite Sensor, MiniMed 530G System, and MiniMed Paradigm Real-Time Revel 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