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 updates to the g5 mobile ios app software and g5 mobile transmitter firmware for dexcom’s g5 mobile continuous glucose monitoring system. The app is being modified to: backfill data from the cgm if there are data gaps within the last 3 hours; include mute override settings, which allow users to hear alerts critical to safe and effective use of the device even when their smart device is muted or turned to a very low volume; and to correct software anomalies. The transmitter firmware is being modified to: transmit data for backfill in the app; improve efficiency of battery usage on the transmitter; expand transmitter database logging to include additional information; support internal engineering efforts; and to correct software anomalies.
| Device | DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | DEXCOM, INC. |
| Date Received | 2016-06-21 |
| Decision Date | 2016-09-16 |
| PMA | P120005 |
| Supplement | S049 |
| Product Code | MDS |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEXCOM, INC. 6340 Sequence Dr san Diego, CA 92121 |
| 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 |