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

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S193 · Decision Aug 25, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    Paradigm Real-Time Revel Insulin Pump & Paradigm Real-Time Insulin Pump.
    PMA Number
    P980022
    Supplement Number
    S193
    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
    August 25, 2016
    Date Received
    July 26, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Add a new testing station to conduct a Manual Bolus Time Test (BTT) in the manufacturing process of the Paradigm Real-Time Insulin Pumps, Paradigm Real-Time Revel Pumps, and MiniMed 530G Insulin Pumps. These pumps are components of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and MiniMed 530G System, respectively. The testing station will be added to the manufacturing facility, located at Juncos, Puerto Rico.

    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