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

    Sensor, Glucose, Invasive

    PMA: P150019 · Supplement: S033 · Decision Dec 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    MiniMed Paradigm Real-Time Revel System
    PMA Number
    P150019
    Supplement Number
    S033
    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 21, 2017
    Date Received
    November 24, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of a new sterilization site for the Enlite Sensor and the Guardian Sensor (3). The Enlite Sensor is a component of MiniMed 530G System, MiniMed Paradigm Real-Time Revel System, and MiniMed iPro2 CGM System with Enlite Sensor. The Guardian Sensor (3) is a component of MiniMed 630G System with SmartGuard 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