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 modifications to the attachment method that secures the disposable housing to the adhesive patch of the sensor pod of the g4 platinum/g5 mobile sensor component which required modifications to the disposable housing, implementation of a semi-automated heat staking machine and a change to the inspection method. The proposed change occurs at tech group, dexcom’s approved supplier. The sensor is a component of the dexcom g4 platinum and dexcom g5 mobile continuous glucose monitoring systems.
| Device | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM,DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | DEXCOM, INC. |
| Date Received | 2015-11-24 |
| Decision Date | 2016-02-05 |
| PMA | P120005 |
| Supplement | S042 |
| Product Code | MDS |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Normal 180 Day 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 |
| 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 |