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.
Manufacturing facility move at one of medtronics tier one supplier for the manual needle-hub assembly and one-press serter base component. The one-press serter is a component of the enlite sensor and guardian sensor (3). The needle-hub assembly component is used in the medtronic enlite sensor and the guardian sensor (3). The enlite sensor is a component of the medtronic minimed 530g, 630g with smartguard, paradigm real-time revel system and ipro2 continuous glucose monitoring systems and guardian sensor (3) are components of the medtronic minimed 670g and minimed 630g continuous glucose monitoring systems
| Device | Minimed 630G System with Smartguard |
| Classification Name | Automated Insulin Dosing , Threshold Suspend |
| Generic Name | Automated Insulin Dosing , Threshold Suspend |
| Applicant | MEDTRONIC MINIMED |
| Date Received | 2018-10-15 |
| Decision Date | 2018-11-14 |
| PMA | P150001 |
| Supplement | S053 |
| 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 |