BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S119 · Decision Dec 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    MINILINK REAL-TIME SYSTEM
    PMA Number
    P980022
    Supplement Number
    S119
    Device Class
    FDA Class 3
    Product Code
    MDS
    Generic Name
    Sensor, glucose, invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 26, 2013
    Date Received
    July 12, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW WATERTIGHT TESTER ACCESSORY DEVICE AS WELL AS LABELINGCHANGES RELATED TO NEW CLEANING AND DISINFECTION PROTOCOLS FOR THE MINILINK TRANSMITTER AND NEW WATERTIGHT TESTER. THE MINILINK TRANSMITTER (MODEL MMT-7703) AND THE WATERTIGHT TESTER (MODEL MMT-7726) ARE COMPONENTS OF THE PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REALTIME SYSTEM, AND MINI LINK REAL-TIME 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