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

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S114 · Decision Apr 4, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    PARADIGM REAL-TIME INSULIN PUMP
    PMA Number
    P980022
    Supplement Number
    S114
    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
    April 4, 2012
    Date Received
    March 5, 2012
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    USE OF AN ALTERNATIVE SUPERCAPACITOR DUE TO A SUPPLY CHAIN PROBLEM. THESUPERCAPACITOR 1037110-003 (NEC P/N: FGH0H154ZF-H5E) WILL REPLACE 1037110-002 (NECPIN: FGH0H154ZF-LE) FOR THE PARADIGM REAL-TIME INSULIN PUMP (MODELS MMT-522, -522K,-722, -722K) AND PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT -523, -523K, -723,-723K). THE PARADIGM REAL-TIME PUMP IS A COMPONENT OF THE PARADIGM REAL-TIME CONTINUOUSGLUCOSE MONITORING SYSTEM. THE PARADIGM REAL-TIME REVEL PUMP IS A COMPONENT OF THEPARADIGM REAL-TIME REVEL CONTINUOUS GLUCOSE MONITORING 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