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 revisions to patient labeling to include instructions for how users should apply a second enlite overtape over the enlite sensor.
| Device | PARADIGM REAL-TIME REVEL SYSTEM |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2016-12-23 |
| Decision Date | 2017-03-27 |
| PMA | P150019 |
| Supplement | S027 |
| Product Code | MDS |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC MINIMED 18000 Devonshire St northridge, CA 91325 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150019 | Original Filing | |
| S065 | 2022-04-01 | 30-day Notice |
| S064 | 2021-11-17 | Special (immediate Track) |
| S063 | 2021-01-27 | Special (immediate Track) |
| S062 | 2020-11-03 | 30-day Notice |
| S061 | 2019-11-29 | 30-day Notice |
| S060 | 2019-10-17 | 30-day Notice |
| S059 | ||
| S058 | 2019-08-21 | 30-day Notice |
| S057 | 2019-07-15 | 30-day Notice |
| S056 | 2019-06-19 | 30-day Notice |
| S055 | ||
| S054 | 2019-02-11 | 30-day Notice |
| S053 | 2019-02-01 | 30-day Notice |
| S052 | 2018-11-07 | 30-day Notice |
| S051 | 2018-11-07 | 30-day Notice |
| S050 | 2018-11-07 | 30-day Notice |
| S049 | 2018-11-02 | 30-day Notice |
| S048 | 2018-10-15 | 30-day Notice |
| S047 | 2018-10-01 | 30-day Notice |
| S046 | 2018-07-16 | 30-day Notice |
| S045 | 2018-07-09 | 30-day Notice |
| S044 | 2018-06-19 | 30-day Notice |
| S043 | 2018-06-07 | Special (immediate Track) |
| S042 | 2018-04-30 | 30-day Notice |
| S041 | 2018-03-26 | 30-day Notice |
| S040 | 2018-03-12 | 30-day Notice |
| S039 | 2018-02-09 | Real-time Process |
| S038 | 2018-02-07 | 30-day Notice |
| S037 | 2018-01-29 | 30-day Notice |
| S036 | 2018-01-29 | 30-day Notice |
| S035 | 2017-12-22 | 30-day Notice |
| S034 | 2017-12-20 | Real-time Process |
| S033 | 2017-11-24 | 30-day Notice |
| S032 | 2017-10-30 | 30-day Notice |
| S031 | 2017-07-17 | 30-day Notice |
| S030 | 2017-05-30 | 30-day Notice |
| S029 | 2017-04-10 | 30-day Notice |
| S028 | 2017-03-31 | 30-day Notice |
| S027 | 2016-12-23 | Real-time Process |
| S026 | 2016-11-28 | 30-day Notice |
| S025 | 2016-11-28 | 30-day Notice |
| S024 | 2016-11-09 | Real-time Process |
| S023 | 2016-11-02 | 30-day Notice |
| S022 | 2016-09-30 | Real-time Process |
| S021 | ||
| S020 | 2016-09-19 | 30-day Notice |
| S019 | ||
| S018 | 2016-07-26 | 30-day Notice |
| S017 | ||
| S016 | 2016-06-15 | 135 Review Track For 30-day Notice |
| S015 | ||
| S014 | 2016-04-27 | 135 Review Track For 30-day Notice |
| S013 | 2016-03-28 | 30-day Notice |
| S012 | 2016-03-25 | 30-day Notice |
| S011 | 2016-03-25 | 30-day Notice |
| S010 | 2016-03-09 | 30-day Notice |
| S009 | 2016-03-07 | 30-day Notice |
| S008 | 2016-02-23 | 30-day Notice |
| S007 | 2016-02-17 | Real-time Process |
| S006 | 2016-02-17 | 30-day Notice |
| S005 | 2016-02-17 | 30-day Notice |
| S004 | 2016-02-17 | 30-day Notice |
| S003 | 2016-02-17 | 30-day Notice |
| S002 | 2016-02-12 | 30-day Notice |
| S001 | 2016-02-12 | 30-day Notice |