This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the dexcom g4 platinum continuous glucose monitoring system. This device is indicated for:the dexcom g4 platinum continuous glucose monitoring system is a glucose monitoring device 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 use as 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 ofhyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the dexcom g4 platinum system results should be based on the trends and patterns seen with several sequential readings over time.
| Device | DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | DEXCOM, INC. |
| Date Received | 2012-04-09 |
| Decision Date | 2012-10-05 |
| Notice Date | 2012-10-12 |
| PMA | P120005 |
| Supplement | S |
| Product Code | MDS |
| Docket Number | 12M-1049 |
| Advisory Committee | Clinical Chemistry |
| 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 |