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

    Sensor, Glucose, Invasive

    PMA: P150019 · Supplement: S009 · Decision Apr 5, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    PARADIGM REAL-TIME REVEL SYSTEM
    PMA Number
    P150019
    Supplement Number
    S009
    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
    April 5, 2016
    Date Received
    March 7, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Relocation of a contract manufacturing facility for printed circuit boards and board stack assemblies used in all Medtronic MiniMed Paradigm Real-Time Revel insulin pumps, Paradigm Real-Time insulin pumps, and MiniMed 530G insulin pumps. The firm is also requesting changes in the manufacturing process sequence as well as updates to mechanical drawings to add vendor name and pump models. The Paradigm Real-Time insulin pumps are a component of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and the Paradigm Real-Time Revel System with Enlite Sensor. The MiniMed 530G insulin pumps are a component of the MiniMed 530G 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