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

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S121 · Decision Sep 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    GUARDIAN REAL-TIME SYSTEM, PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL PUMP
    PMA Number
    P980022
    Supplement Number
    S121
    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
    September 13, 2012
    Date Received
    August 17, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    REINSTATEMENT OF THE AYUTTHAYA, THAILAND FACILITY AS AN ADDITIONAL FACILITY FOR THE MANUFACTURE OF PRINTED CIRCUIT BOARD ASSEMBLIES AND STACK SUBASSEMBLIES USED BY MEDTRONIC MINIMED IN THE PRODUCTION OF THE PARADIGM REAL-TIME INSULIN PUMP (MODELS MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT-523, MMT-523K, MMT-723, AND MMT-723K)) AND GUARDIAN REAL-TIME MONITOR (CSS7100, CSS7 100K). THE PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP, AND GUARDIAN REAL-TIME MONITOR ARE COMPONENTS OF THE DEVICES.

    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