BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P120005 · Supplement: S028 · Decision Jan 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM SHARE SYSTEM
    PMA Number
    P120005
    Supplement Number
    S028
    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
    January 23, 2015
    Date Received
    September 12, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    FOR THE ADDITION OF A BLUETOOTH LOW ENERGY (BLE) RADIO TO BOTH THEADULT (MT20649) AND PEDIATRIC (MT22430) VERSIONS OF THE DEXCOM G4 PLATINUM RECEIVER,IDENTIFIED AS THE DEXCOM G4 PLATINUM RECEIVER WITH SHARE (ADULT - MT22495, PEDIATRIC -MT22608), AND FOR A MODIFICATION TO THE DEXCOM SHARE SYSTEM (STA-GL-400) ALLOWING THEDEXCOM G4 PLATINUM RECEIVER WITH SHARE TO COMMUNICATE DIRECTLY WITH THE DEXCOM SHARE2MOBILE APPLICATION INSTALLED ON A USER¿S APPLE MOBILE DEVICE. THE DEXCOM RECEIVER WITH SHAREIS A COMPONENT OF THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, THEDEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM, AND THE DEXCOMSHARE SYSTEM. THOUGH THE INDICATIONS FOR USE FOR THE DEXCOM G4 PLATINUM CONTINUOUSGLUCOSE MONITORING SYSTEM AND THE DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSEMONITORING SYSTEM ARE UNCHANGED BY THIS SUPPLEMENT, THE DEXCOM SHARE SYSTEM, AS MODIFIED,WILL BE MARKETED UNDER THE TRADE NAME DEXCOM SHARE SYSTEM AND IS INDICATED FOR:THE PURPOSE OF DEXCOM SHARE IS TO NOTIFY ANOTHER PERSON, THE FOLLOWER, OF THE PATIENT¿SDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM SENSOR GLUCOSEINFORMATION. DEXCOM SHARE PROVIDES SECONDARY NOTIFICATION AND DOES NOT REPLACE REAL TIMECONTINUOUS GLUCOSE MONITORING (G4 PLATINUM SYSTEM) OR STANDARD HOME BLOOD GLUCOSEMONITORING.

    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