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 replacement of an obsolete lcd in the receiver assembly with a similar component and minor modifications to the receiver firmware to accommodate the new hardware.
| Device | DEXCOM SEVEN PLUS SYSTEM |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | DEXCOM, INC. |
| Date Received | 2011-04-08 |
| Decision Date | 2011-06-03 |
| PMA | P050012 |
| Supplement | S037 |
| 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 |