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

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S109 · Decision Mar 9, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P980022
    Supplement Number
    S109
    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
    March 9, 2012
    Date Received
    February 8, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF A NEW CLEANING SYSTEM CALLED ISOPROPYL ALCOHOL RECIRCULATING CLEANING OR IPARC. THE IPARC SYSTEM IS USED TO CLEAN THE SENSOR BASE AND NEEDLE ASSEMBLY COMPONENTS OF THE SOF-SENSOR GLUCOSE SENSOR (MMT-7002, MMT-7003). THE SOF-SENSOR IS A COMPONENT OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REAL-TIME SYSTEM, CGMS IPRO SYSTEM AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM) 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