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 software modifications to the existing firmware update tool to allow the tool to be run on mac os x operating systems, to improve the runtime and simplify installation steps on currently supported windows platforms, to add notifications whichalert users compatibility issues with usb 3. 0 ports, and to improve compatibility with future dexcom products. The device, as modified, will be marketed under the trade name dexcom g4platinum continuous glucose monitoring system and is indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The system is intended for single patient use and requires a prescription. The dexcom g4 platinum system is indicated for useas an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The dexcom g4 platinum system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the dexcom g4platinum system results should be based on the trends and patterns seen with several sequential readings over time.
| Device | DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | DEXCOM, INC. |
| Date Received | 2015-05-14 |
| Decision Date | 2015-07-02 |
| PMA | P120005 |
| Supplement | S036 |
| 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 |