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 the following changes to the dexcom studio software: support was added for windows 8, open office, and canadian english and canadian french installations; improved system performance for large clinics that manage large numbers of patients; the word blinded was added to every chart when the receiver data is downloaded in blinded mode; the tooltip was translated into various languages; and labeling changes were made to the dexcom studio software guide, g4 sensor manual, and receiver replacement guide.
| Device | DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | DEXCOM, INC. |
| Date Received | 2013-12-06 |
| Decision Date | 2014-03-05 |
| PMA | P050012 |
| Supplement | S052 |
| 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. 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 |