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.
Installation of additional equipment for the automation of the gox patterning stage of guardian glucose sensor (3) to increase production capacity. The guardian glucose sensor is a component of the minimed 630, minimed 670, and the guardian connect systems.
| Device | Guardian Glucose Sensor (3) |
| Classification Name | Automated Insulin Dosing Device System, Single Hormonal Control |
| Generic Name | Automated Insulin Dosing Device System, Single Hormonal Control |
| Applicant | MEDTRONIC MINIMED, INC. |
| Date Received | 2018-05-11 |
| Decision Date | 2018-06-07 |
| PMA | P160017 |
| Supplement | S042 |
| Product Code | OZP |
| 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, INC. 18000 Devonshire Street northridge, CA 91325 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160017 | Original Filing | |
| S106 | 2022-11-16 | Special (immediate Track) |
| S105 | 2022-11-04 | 30-day Notice |
| S104 | ||
| S103 | 2022-09-29 | 30-day Notice |
| S102 | 2022-09-14 | Special (immediate Track) |
| S101 | ||
| S100 | 2022-04-01 | 30-day Notice |
| S099 | 2022-03-30 | 30-day Notice |
| S098 | 2022-03-29 | 30-day Notice |
| S097 | ||
| S096 | ||
| S095 | 2021-11-17 | Special (immediate Track) |
| S094 | 2021-09-20 | 30-day Notice |
| S093 | ||
| S092 | 2021-06-29 | 30-day Notice |
| S091 | ||
| S090 | 2021-01-27 | Special (immediate Track) |
| S089 | ||
| S088 | 2020-11-03 | 30-day Notice |
| S087 | 2020-08-28 | Real-time Process |
| S086 | 2020-08-04 | 30-day Notice |
| S085 | 2020-05-26 | 30-day Notice |
| S084 | ||
| S083 | ||
| S082 | 2020-03-30 | 30-day Notice |
| S081 | 2020-01-08 | 30-day Notice |
| S080 | 2019-12-23 | 30-day Notice |
| S079 | 2019-11-29 | 30-day Notice |
| S078 | 2019-11-27 | 30-day Notice |
| S077 | 2019-11-27 | 30-day Notice |
| S076 | ||
| S075 | 2019-10-17 | 30-day Notice |
| S074 | 2019-10-11 | 30-day Notice |
| S073 | 2019-09-30 | 30-day Notice |
| S072 | ||
| S071 | ||
| S070 | 2019-08-21 | 30-day Notice |
| S069 | 2019-07-15 | 30-day Notice |
| S068 | ||
| S067 | 2019-06-19 | 30-day Notice |
| S066 | 2019-06-13 | 30-day Notice |
| S065 | 2019-05-21 | 30-day Notice |
| S064 | 2019-05-17 | 30-day Notice |
| S063 | ||
| S062 | ||
| S061 | ||
| S060 | 2019-04-03 | 30-day Notice |
| S059 | 2019-04-01 | 30-day Notice |
| S058 | 2019-02-25 | 30-day Notice |
| S057 | 2019-02-11 | 30-day Notice |
| S056 | ||
| S055 | 2019-02-01 | 30-day Notice |
| S054 | 2019-01-22 | 30-day Notice |
| S053 | 2018-11-02 | 30-day Notice |
| S052 | 2018-10-15 | 30-day Notice |
| S051 | 2018-08-31 | Real-time Process |
| S050 | 2018-08-07 | Normal 180 Day Track No User Fee |
| S049 | 2018-07-23 | 30-day Notice |
| S048 | 2018-07-23 | Normal 180 Day Track |
| S047 | 2018-07-09 | 30-day Notice |
| S046 | 2018-07-02 | 30-day Notice |
| S045 | 2018-06-19 | 30-day Notice |
| S044 | 2018-06-07 | Special (immediate Track) |
| S043 | 2018-06-04 | 30-day Notice |
| S042 | 2018-05-11 | 30-day Notice |
| S041 | 2018-03-29 | 30-day Notice |
| S040 | 2018-03-26 | 30-day Notice |
| S039 | 2018-03-12 | 30-day Notice |
| S038 | 2018-02-23 | 30-day Notice |
| S037 | 2018-02-09 | Real-time Process |
| S036 | 2018-02-07 | 30-day Notice |
| S035 | 2018-01-31 | 30-day Notice |
| S034 | 2018-01-30 | 30-day Notice |
| S033 | 2018-01-29 | 30-day Notice |
| S032 | 2018-01-29 | 30-day Notice |
| S031 | 2018-01-26 | Panel Track |
| S030 | 2018-01-23 | Special (immediate Track) |
| S029 | 2017-12-22 | 30-day Notice |
| S028 | 2017-11-30 | Real-time Process |
| S027 | 2017-11-24 | Normal 180 Day Track No User Fee |
| S026 | 2017-11-24 | 30-day Notice |
| S025 | ||
| S024 | 2017-10-10 | 30-day Notice |
| S023 | 2017-10-06 | 30-day Notice |
| S022 | ||
| S021 | 2017-09-29 | 30-day Notice |
| S020 | 2017-09-27 | Normal 180 Day Track |
| S019 | 2017-09-14 | 30-day Notice |
| S018 | 2017-08-04 | Real-time Process |
| S017 | 2017-08-02 | Panel Track |
| S016 | 2017-07-21 | Real-time Process |
| S015 | ||
| S014 | 2017-06-02 | Special (immediate Track) |
| S013 | 2017-05-08 | 30-day Notice |
| S012 | 2017-04-10 | 30-day Notice |
| S011 | 2017-03-31 | 30-day Notice |
| S010 | 2017-03-24 | 30-day Notice |
| S009 | ||
| S008 | 2016-12-30 | Real-time Process |
| S007 | 2016-11-28 | 30-day Notice |
| S006 | 2016-11-28 | 30-day Notice |
| S005 | 2016-11-02 | 30-day Notice |
| S004 | 2016-10-27 | Normal 180 Day Track No User Fee |
| S003 | 2016-10-26 | Normal 180 Day Track |
| S002 | 2016-10-14 | 30-day Notice |
| S001 | 2016-10-12 | 30-day Notice |