This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the dexcom g5 mobile continuous glucose monitoring system (dexcom g5) is a glucose monitoring system indicated for the management of diabetes in persons age 2 years and older. The dexcom g5 is designed to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the dexcom g5 results should be based on the glucose trends and several sequential readings over time. The dexcom g5 also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The dexcom g5 is intended for single patient use and requires a prescription. The g5 mobile continuous glucose monitoring system consists of the following devices: sensor, transmitter (with onboard algorithm), receiver, and mobile app. The sensor is a small flexible metal filament that is inserted into subcutaneous tissue where it enzymatically generates electrical current in response to the presence of glucose. The transmitter is connected to the sensor and is worn on the surface of the body. It samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm. The transmitter sends glucose data to both the receiver and the mobile app and receives blood glucose calibration and other user inputs from these display devices. The receiver displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 24 hours) from the transmitter. The receiver alerts the patient when glucose levels are outside of a target zone (factory set at 55 mg/dl, in addition to up to two user defined limits), when it is time to enter a blood glucose value from a fingerstick to calibrate the system, and for other important system conditions. The mobile app provides an alternative user interface to the receiver for those users with a compatible apple ios device. It provides similar glucose display, alert, and calibration functionality to the receiver and additionally provides connectivity to the dexcom share service.
| Device | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Classification Name | Sensor, Glucose, Invasive, Non-adjunctive |
| Generic Name | Sensor, Glucose, Invasive, Non-adjunctive |
| Applicant | DEXCOM, INC. |
| Date Received | 2015-09-25 |
| Decision Date | 2016-12-20 |
| Notice Date | 2016-12-21 |
| PMA | P120005 |
| Supplement | S041 |
| Product Code | PQF |
| Docket Number | 16M-4483 |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEXCOM, INC. 6340 Sequence Dr san Diego, CA 92121 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120005 | Original Filing | |
| S090 | 2022-10-14 | Normal 180 Day Track No User Fee |
| S089 | 2021-09-29 | Real-time Process |
| S088 | ||
| S087 | 2020-08-06 | Normal 180 Day Track No User Fee |
| S086 | 2019-12-09 | 30-day Notice |
| S085 | ||
| S084 | ||
| S083 | 2019-06-27 | Normal 180 Day Track No User Fee |
| S082 | 2019-06-11 | Real-time Process |
| S081 | 2019-03-12 | Real-time Process |
| S080 | 2019-01-22 | Normal 180 Day Track No User Fee |
| S079 | 2018-11-05 | 30-day Notice |
| S078 | 2018-09-07 | 30-day Notice |
| S077 | 2018-08-08 | Real-time Process |
| S076 | 2018-05-23 | 30-day Notice |
| S075 | 2018-05-18 | 30-day Notice |
| S074 | 2018-05-14 | 30-day Notice |
| S073 | 2018-04-04 | Real-time Process |
| S072 | ||
| S071 | 2018-02-27 | 30-day Notice |
| S070 | ||
| S069 | 2017-12-11 | 30-day Notice |
| S068 | 2017-10-16 | 30-day Notice |
| S067 | 2017-10-10 | Normal 180 Day Track No User Fee |
| S066 | 2017-08-17 | 30-day Notice |
| S065 | 2017-07-10 | Real-time Process |
| S064 | 2017-06-29 | Real-time Process |
| S063 | 2017-04-10 | 30-day Notice |
| S062 | 2017-04-04 | 30-day Notice |
| S061 | 2017-04-03 | 30-day Notice |
| S060 | 2017-03-01 | 135 Review Track For 30-day Notice |
| S059 | 2017-01-19 | Normal 180 Day Track No User Fee |
| S058 | 2016-12-21 | 30-day Notice |
| S057 | 2016-10-20 | Normal 180 Day Track |
| S056 | 2016-10-11 | 30-day Notice |
| S055 | 2016-09-14 | Real-time Process |
| S054 | ||
| S053 | 2016-07-28 | Real-time Process |
| S052 | 2016-07-27 | 30-day Notice |
| S051 | 2016-07-15 | 30-day Notice |
| S050 | 2016-06-22 | Normal 180 Day Track |
| S049 | 2016-06-21 | Real-time Process |
| S048 | 2016-05-06 | Real-time Process |
| S047 | 2016-04-26 | Real-time Process |
| S046 | 2016-03-25 | 30-day Notice |
| S045 | ||
| S044 | 2015-12-17 | 30-day Notice |
| S043 | 2015-12-15 | 30-day Notice |
| S042 | 2015-11-24 | Normal 180 Day Track |
| S041 | 2015-09-25 | Panel Track |
| S040 | 2015-09-25 | 135 Review Track For 30-day Notice |
| S039 | 2015-09-23 | 30-day Notice |
| S038 | 2015-08-10 | Real-time Process |
| S037 | 2015-07-16 | Real-time Process |
| S036 | 2015-05-14 | Real-time Process |
| S035 | 2015-05-08 | 30-day Notice |
| S034 | 2015-03-17 | 30-day Notice |
| S033 | 2015-02-25 | Normal 180 Day Track |
| S032 | 2014-12-23 | 30-day Notice |
| S031 | 2014-11-26 | Panel Track |
| S030 | 2014-11-14 | 30-day Notice |
| S029 | 2014-10-27 | 30-day Notice |
| S028 | 2014-09-12 | Normal 180 Day Track |
| S027 | 2014-07-24 | 30-day Notice |
| S026 | 2014-07-21 | Real-time Process |
| S025 | 2014-06-26 | 30-day Notice |
| S024 | 2014-06-18 | 30-day Notice |
| S023 | 2014-06-16 | 30-day Notice |
| S022 | 2014-06-13 | 30-day Notice |
| S021 | 2014-06-09 | 30-day Notice |
| S020 | 2014-05-19 | 30-day Notice |
| S019 | 2014-04-16 | Real-time Process |
| S018 | 2014-04-23 | Panel Track |
| S017 | 2014-04-02 | 30-day Notice |
| S016 | ||
| S015 | ||
| S014 | 2013-12-06 | Real-time Process |
| S013 | 2013-09-30 | Real-time Process |
| S012 | 2013-09-20 | 30-day Notice |
| S011 | 2013-09-16 | Normal 180 Day Track |
| S010 | 2013-07-26 | 30-day Notice |
| S009 | 2013-07-24 | Normal 180 Day Track |
| S008 | 2013-07-13 | 30-day Notice |
| S007 | 2013-07-10 | 30-day Notice |
| S006 | 2013-06-04 | 30-day Notice |
| S005 | 2013-05-20 | Real-time Process |
| S004 | 2013-03-11 | 30-day Notice |
| S003 | 2013-03-04 | 30-day Notice |
| S002 | 2013-02-19 | Panel Track |
| S001 | 2012-12-05 | 30-day Notice |