BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S159 · Decision Nov 12, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    SOF-SENSOR
    PMA Number
    P980022
    Supplement Number
    S159
    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
    November 12, 2015
    Date Received
    July 11, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN INCOMING RECEIVING MATERIAL SPECIFICATION CHANGE OF A CRITICAL DEVICE COMPONENT (GOX) USED IN THE SENSOR FABRICATION PROCESS FOR THE ENLITE SENSOR (MMT-7008) AND SOF-SENSOR (MMT-7002, MMT-7003). THESE SENSORS ARE COMPONENTS OF THE MINIMED 530G SYSTEM AND PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REAL-TIME CGM SYSTEM, MINILINK REAL-TIME SYSTEM, IPRO RECORDER CGM SYSTEM, AND IPRO2 PROFESSIONAL CGM SYSTEM, RESPECTIVELY.

    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