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 an alternative press to increase manufacturing capacity for the guardian sensor (3) continuous glucose monitoring sensor. The guardian sensor (3) is a component of the minimed 630g, guardian connect system, and minimed 670g systems.
| Device | Medtronic MiniMed 630G System with Guardian Sensor (3)/ Guardian Sensor (3) |
| Classification Name | Automated Insulin Dosing , Threshold Suspend |
| Generic Name | Automated Insulin Dosing , Threshold Suspend |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2018-07-02 |
| Decision Date | 2018-08-03 |
| PMA | P150001 |
| Supplement | S048 |
| Product Code | OZO |
| 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 |
|---|---|---|
| P150001 | Original Filing | |
| S102 | 2022-11-16 | Special (immediate Track) |
| S101 | 2022-11-04 | 30-day Notice |
| S100 | ||
| S099 | 2022-09-14 | Special (immediate Track) |
| S098 | 2022-04-01 | 30-day Notice |
| S097 | 2022-03-30 | 30-day Notice |
| S096 | 2022-03-29 | 30-day Notice |
| S095 | ||
| S094 | ||
| S093 | 2021-11-17 | Special (immediate Track) |
| S092 | 2021-09-20 | 30-day Notice |
| S091 | 2021-06-29 | 30-day Notice |
| S090 | 2021-01-27 | Special (immediate Track) |
| S089 | 2020-11-03 | 30-day Notice |
| S088 | 2020-08-28 | Real-time Process |
| S087 | 2020-08-04 | 30-day Notice |
| S086 | 2020-05-26 | 30-day Notice |
| S085 | ||
| S084 | ||
| S083 | 2020-03-30 | 30-day Notice |
| S082 | 2020-01-08 | 30-day Notice |
| S081 | 2019-12-23 | 30-day Notice |
| S080 | 2019-11-29 | 30-day Notice |
| S079 | 2019-11-27 | 30-day Notice |
| S078 | 2019-11-27 | 30-day Notice |
| S077 | 2019-10-17 | 30-day Notice |
| S076 | 2019-10-11 | 30-day Notice |
| S075 | 2019-09-30 | 30-day Notice |
| S074 | ||
| S073 | 2019-08-21 | 30-day Notice |
| S072 | 2019-07-15 | 30-day Notice |
| S071 | 2019-06-19 | 30-day Notice |
| S070 | 2019-06-13 | 30-day Notice |
| S069 | 2019-05-21 | 30-day Notice |
| S068 | 2019-05-17 | 30-day Notice |
| S067 | ||
| S066 | ||
| S065 | ||
| S064 | 2019-04-03 | 30-day Notice |
| S063 | 2019-04-01 | 30-day Notice |
| S062 | 2019-02-25 | 30-day Notice |
| S061 | 2019-02-11 | 30-day Notice |
| S060 | ||
| S059 | 2019-02-01 | 30-day Notice |
| S058 | 2019-01-22 | 30-day Notice |
| S057 | ||
| S056 | 2018-11-07 | 30-day Notice |
| S055 | 2018-11-07 | 30-day Notice |
| S054 | 2018-11-02 | 30-day Notice |
| S053 | 2018-10-15 | 30-day Notice |
| S052 | 2018-08-31 | Real-time Process |
| S051 | 2018-07-23 | 30-day Notice |
| S050 | 2018-07-23 | Normal 180 Day Track |
| S049 | 2018-07-09 | 30-day Notice |
| S048 | 2018-07-02 | 30-day Notice |
| S047 | 2018-06-19 | 30-day Notice |
| S046 | 2018-06-07 | Special (immediate Track) |
| S045 | 2018-06-04 | 30-day Notice |
| S044 | 2018-05-11 | 30-day Notice |
| S043 | 2018-03-29 | 30-day Notice |
| S042 | 2018-03-26 | 30-day Notice |
| S041 | 2018-03-12 | 30-day Notice |
| S040 | 2018-02-23 | 30-day Notice |
| S039 | 2018-02-09 | Real-time Process |
| S038 | 2018-02-07 | 30-day Notice |
| S037 | 2018-01-31 | 30-day Notice |
| S036 | 2018-01-30 | 30-day Notice |
| S035 | 2018-01-29 | 30-day Notice |
| S034 | 2018-01-29 | 30-day Notice |
| S033 | 2018-01-23 | Special (immediate Track) |
| S032 | 2017-12-22 | 30-day Notice |
| S031 | 2017-11-30 | Real-time Process |
| S030 | 2017-11-24 | 30-day Notice |
| S029 | ||
| S028 | 2017-10-30 | Normal 180 Day Track |
| S027 | 2017-10-30 | 30-day Notice |
| S026 | 2017-10-10 | 30-day Notice |
| S025 | 2017-10-06 | 30-day Notice |
| S024 | 2017-09-29 | 30-day Notice |
| S023 | 2017-09-14 | 30-day Notice |
| S022 | 2017-08-04 | Real-time Process |
| S021 | 2017-08-02 | Panel Track |
| S020 | 2017-07-21 | Real-time Process |
| S019 | 2017-07-17 | 30-day Notice |
| S018 | ||
| S017 | 2017-06-02 | Special (immediate Track) |
| S016 | 2017-05-30 | 30-day Notice |
| S015 | 2017-05-08 | 30-day Notice |
| S014 | 2017-04-10 | 30-day Notice |
| S013 | 2017-04-07 | Real-time Process |
| S012 | 2017-03-31 | 30-day Notice |
| S011 | 2017-03-24 | 30-day Notice |
| S010 | ||
| S009 | 2016-12-23 | Real-time Process |
| S008 | 2016-12-14 | Normal 180 Day Track |
| S007 | 2016-12-12 | 30-day Notice |
| S006 | 2016-11-28 | 30-day Notice |
| S005 | 2016-11-28 | 30-day Notice |
| S004 | 2016-11-02 | 30-day Notice |
| S003 | 2016-10-24 | Real-time Process |
| S002 | 2016-10-14 | 30-day Notice |
| S001 | 2016-09-02 | 30-day Notice |