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 1) the addition of new components to the global transmitter/global receiver system allowing communication at 2. 4 ghz; 2) minor modifications to the applicator bail and safety card; and 3) updates to the optional data manager software that is provided with the seven plus cgm system. The device, as modified, will be marketed under the trade name dexcom color continuous glucose monitoring (cgm) system, and is a glucose-monitoring device indicated for detecting and tracking glucose trends and patterns to aid in thedetection of episodes of hyperglycemia and hypoglycemia in adults with diabetes. The system is intended for single patient use and requires a prescription.
| Device | DEXCOM CGM |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | DEXCOM, INC. |
| Date Received | 2012-02-21 |
| Decision Date | 2012-08-17 |
| PMA | P050012 |
| Supplement | S045 |
| 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. 5555 Oberlin Dr san Diego, CA 92121 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050012 | Original Filing | |
| S052 | 2013-12-06 | Real-time Process |
| S051 | 2013-07-26 | 30-day Notice |
| S050 | 2012-09-25 | 135 Review Track For 30-day Notice |
| S049 | 2012-09-24 | 30-day Notice |
| S048 | 2012-07-05 | 30-day Notice |
| S047 | 2012-05-30 | 30-day Notice |
| S046 | 2012-03-16 | 135 Review Track For 30-day Notice |
| S045 | 2012-02-21 | Normal 180 Day Track |
| S044 | 2012-01-03 | Real-time Process |
| S043 | 2011-12-21 | 30-day Notice |
| S042 | 2011-10-17 | 135 Review Track For 30-day Notice |
| S041 | 2011-08-15 | 135 Review Track For 30-day Notice |
| S040 | ||
| S039 | 2011-08-15 | 135 Review Track For 30-day Notice |
| S038 | 2011-07-14 | 30-day Notice |
| S037 | 2011-04-08 | Real-time Process |
| S036 | 2011-01-31 | 30-day Notice |
| S035 | 2010-12-08 | 135 Review Track For 30-day Notice |
| S034 | 2010-11-12 | 30-day Notice |
| S033 | 2010-11-12 | 135 Review Track For 30-day Notice |
| S032 | 2010-08-04 | 30-day Notice |
| S031 | 2010-07-30 | Real-time Process |
| S030 | 2010-07-30 | Real-time Process |
| S029 | 2010-07-30 | 30-day Notice |
| S028 | 2010-07-28 | 30-day Notice |
| S027 | 2010-07-13 | Real-time Process |
| S026 | ||
| S025 | 2010-06-15 | Special (immediate Track) |
| S024 | 2010-05-12 | 30-day Notice |
| S023 | ||
| S022 | 2009-12-30 | 30-day Notice |
| S021 | 2009-11-05 | 30-day Notice |
| S020 | 2009-08-26 | 30-day Notice |
| S019 | 2009-08-20 | 30-day Notice |
| S018 | 2009-03-09 | Real-time Process |
| S017 | 2008-09-23 | Normal 180 Day Track |
| S016 | 2008-08-04 | Normal 180 Day Track |
| S015 | 2008-06-19 | 30-day Notice |
| S014 | 2008-04-01 | Real-time Process |
| S013 | 2007-12-13 | 30-day Notice |
| S012 | 2007-08-20 | Normal 180 Day Track No User Fee |
| S011 | 2007-06-05 | Normal 180 Day Track |
| S010 | 2007-04-16 | Real-time Process |
| S009 | 2007-03-26 | 30-day Notice |
| S008 | 2007-03-01 | 30-day Notice |
| S007 | 2007-02-06 | 30-day Notice |
| S006 | 2007-01-03 | 30-day Notice |
| S005 | 2006-12-06 | 30-day Notice |
| S004 | 2006-09-07 | 30-day Notice |
| S003 | 2006-08-21 | 30-day Notice |
| S002 | 2006-07-28 | Real-time Process |
| S001 | 2006-06-19 | Panel Track |