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

    Sensor, Glucose, Invasive

    PMA: P140015 · Supplement: S007 · Decision Jan 28, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
    PMA Number
    P140015
    Supplement Number
    S007
    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
    January 28, 2016
    Date Received
    December 30, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES TO THE PACKAGING VERIFICATION PROCESSES TO REPLACE 100% VISUAL INSPECTION WITH 100% PACKAGE CONTENTS VERIFICATION USING VALIDATED CHECKWEIGHT SCALE, AND CHANGES TO THE LABELING VERIFICATION PROCESS TO REPLACE 100% VISUAL VERIFICATION WITH ONCE-DAILY VISUAL INSPECTION OF A RETAINED LABEL FOR THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM 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