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

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S189 · Decision Dec 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM
    PMA Number
    P980022
    Supplement Number
    S189
    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 23, 2015
    Date Received
    November 27, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    TRANSFER OF TWO SUB-ASSEMBLY PROCESSES FOR THE PARADIGMREAL? TIME, PARADIGM REAL? TIME REVEL, AND MINIMED 530G INSULIN PUMPS FROM MEDTRONIC MINIMED IN NORTHRIDGE, CA TO MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC). THE PARADIGM REAL ]TIME AND REAL? TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGMREAL?]TIME AND REAL? TIME REVEL SYSTEMS, RESPECTIVELY. THE MINIMED 530G INSULIN PUMP IS 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