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 1) minor design changes to the electronics board stack used in the 630g insulin pump; 2) a new supplier for the electronics board stack; 3) an updated pump software version; and 4) an extension to the 630g insulin pump shelf life from 185 days to 1095 days.
| Device | MiniMed 630G Insulin Pump |
| Classification Name | Automated Insulin Dosing , Threshold Suspend |
| Generic Name | Automated Insulin Dosing , Threshold Suspend |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2017-10-30 |
| Decision Date | 2017-12-20 |
| PMA | P150001 |
| Supplement | S028 |
| Product Code | OZO |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |