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.
Addition of drying equipment used in the production of the guardian sensor (3) and enlite sensor. The guardian sensor (3) is a component of the minimed 670g, the guardian connect, and the minimed 630g system. The enlite sensor is a component of the minimed ipro 2, minimed paradigm real-time revel, minimed 530g, and minimed 630g systems.
| Device | MiniMed Paradigm Real-Time Revel System |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2018-07-09 |
| Decision Date | 2018-08-06 |
| PMA | P150019 |
| Supplement | S045 |
| 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 |