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.
| Device | MiniMed 630G System with SmartGuard, MiniMed 630G System with GS3, GS3 Transfer to MPROC |
| Generic Name | Automated Insulin Dosing , Threshold Suspend |
| Applicant | MEDTRONIC MINIMED18000 Devonshire Stnorthridge, CA 91325 PMA NumberP150001 Supplement NumberS101 Date Received11/04/2022 Decision Date12/08/2022 Product Code OZO Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-04 |
| Decision Date | 2022-12-08 |
| PMA | P150001 |
| Supplement | S101 |
| 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 PMA NumberP150001 Supplement NumberS101 Date Received11/04/2022 Decision Date12/08/2022 Product Code OZO Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement addition Of A New Supplier For The Thermoformed Packaging Tray For The Enlite Sensor And The Guardian Sensor (3). The Enlite Sensor Is A Components Of The MiniMed 530G, 630G, Paradigm Real-Time Revel, And IPro2 CGM Systems. The Guardian Sensor (3) Is A Component Of The MiniMed 630G, Guardian Connect, 670G And 770G Systems |
| 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 |