BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S143 · Decision Sep 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    MINILINK REAL-TIME SYSTEM,IPRO RECORDER CGMS SYSTEM,IPRO2 RECORDER CGM SYSTEM
    PMA Number
    P980022
    Supplement Number
    S143
    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
    September 25, 2014
    Date Received
    November 7, 2013
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE SUPPLIER AND MATERIAL OF THE BATTERY ANODE FOR THE MINILINK REAL-TIME TRANSMITTER (MODEL: MMT-7703), THE IPRO2 RECORDER (MODEL: MMT-7741) AND THE MINILINK REAL-TIME TRANSMITTER (MODEL: MMT-7703), WHICHARE COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, IPRO2 PROFESSIONAL CGM AND MINIMED 530G SYSTEMS.

    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