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.
Transition of the manufacturing of the tyvek lids used for packaging the enlite sensor component from the supplier’s facility in philadelphia to oshkosh, wisconsin. Additionally, the facility transition includes new manufacturing assets including a coater and die cut lid press. The enlite sensor is a component of the paradigm real-time revel system with enlite sensor.
| Device | PARADIGM REAL-TIME REVEL SYSTEM |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2016-02-17 |
| Decision Date | 2016-03-17 |
| PMA | P150019 |
| Supplement | S005 |
| Product Code | MDS |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |