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 |
Generic Name | Automated Insulin Dosing , Threshold Suspend |
Applicant | MEDTRONIC MINIMED18000 Devonshire Stnorthridge, CA 91325 PMA NumberP150001 Supplement NumberS102 Date Received11/16/2022 Decision Date12/16/2022 Product Code OZO Advisory Committee Clinical Chemistry Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
Date Received | 2022-11-16 |
Decision Date | 2022-12-16 |
PMA | P150001 |
Supplement | S102 |
Product Code | OZO |
Advisory Committee | Clinical Chemistry |
Supplement Type | Special (immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | MEDTRONIC MINIMED 18000 Devonshire St northridge, CA 91325 PMA NumberP150001 Supplement NumberS102 Date Received11/16/2022 Decision Date12/16/2022 Product Code OZO Advisory Committee Clinical Chemistry Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Adding Supplemental Labeling Information To The Current Instructions For Use (IFU) For The Medtronic MiniMed 630G, 670G, And 770G Pump 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 |