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 an incoming receiving material specification change of a critical device component (gox) used in the sensor fabrication process for the enlite sensor (mmt-7008) and sof-sensor (mmt-7002, mmt-7003). These sensors are components of the minimed 530g system and paradigm real-time system, paradigm real-time revel system, guardian real-time cgm system, minilink real-time system, ipro recorder cgm system, and ipro2 professional cgm system, respectively.
| Device | ENLITE SENSOR |
| Classification Name | Automated Insulin Dosing , Threshold Suspend |
| Generic Name | Automated Insulin Dosing , Threshold Suspend |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2014-07-11 |
| Decision Date | 2015-11-12 |
| PMA | P120010 |
| Supplement | S029 |
| 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 Inc. 18000 Devonshire Street northridge, CA 91325-1219 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120010 | Original Filing | |
| S142 | 2022-11-04 | 30-day Notice |
| S141 | 2022-04-01 | 30-day Notice |
| S140 | 2021-11-17 | Special (immediate Track) |
| S139 | 2021-01-27 | Special (immediate Track) |
| S138 | 2020-11-03 | 30-day Notice |
| S137 | 2019-11-29 | 30-day Notice |
| S136 | 2019-10-17 | 30-day Notice |
| S135 | 2019-10-11 | 30-day Notice |
| S134 | ||
| S133 | 2019-08-21 | 30-day Notice |
| S132 | 2019-07-15 | 30-day Notice |
| S131 | 2019-06-19 | 30-day Notice |
| S130 | ||
| S129 | 2019-02-11 | 30-day Notice |
| S128 | 2019-02-01 | 30-day Notice |
| S127 | ||
| S126 | 2018-11-07 | 30-day Notice |
| S125 | 2018-11-07 | 30-day Notice |
| S124 | 2018-11-07 | 30-day Notice |
| S123 | 2018-11-02 | 30-day Notice |
| S122 | 2018-10-15 | 30-day Notice |
| S121 | 2018-10-01 | 30-day Notice |
| S120 | 2018-07-16 | 30-day Notice |
| S119 | 2018-07-09 | 30-day Notice |
| S118 | 2018-06-19 | 30-day Notice |
| S117 | 2018-06-07 | Special (immediate Track) |
| S116 | 2018-04-30 | 30-day Notice |
| S115 | 2018-03-26 | 30-day Notice |
| S114 | 2018-03-12 | 30-day Notice |
| S113 | 2018-02-09 | Real-time Process |
| S112 | 2018-02-07 | 30-day Notice |
| S111 | 2018-01-29 | 30-day Notice |
| S110 | 2018-01-29 | 30-day Notice |
| S109 | 2017-12-22 | 30-day Notice |
| S108 | 2017-12-20 | Real-time Process |
| S107 | 2017-11-24 | 30-day Notice |
| S106 | 2017-10-30 | 30-day Notice |
| S105 | 2017-07-17 | 30-day Notice |
| S104 | 2017-05-30 | 30-day Notice |
| S103 | 2017-04-10 | 30-day Notice |
| S102 | 2017-03-31 | 30-day Notice |
| S101 | 2017-02-03 | Normal 180 Day Track No User Fee |
| S100 | 2016-12-23 | Real-time Process |
| S099 | 2016-11-28 | 30-day Notice |
| S098 | 2016-11-28 | 30-day Notice |
| S097 | 2016-11-02 | 30-day Notice |
| S096 | ||
| S095 | 2016-09-19 | 30-day Notice |
| S094 | ||
| S093 | 2016-07-26 | 30-day Notice |
| S092 | 2016-07-21 | 30-day Notice |
| S091 | 2016-06-15 | 135 Review Track For 30-day Notice |
| S090 | ||
| S089 | 2016-04-27 | 135 Review Track For 30-day Notice |
| S088 | 2016-03-28 | 30-day Notice |
| S087 | 2016-03-25 | 30-day Notice |
| S086 | 2016-03-25 | 30-day Notice |
| S085 | 2016-03-09 | 30-day Notice |
| S084 | 2016-03-07 | 30-day Notice |
| S083 | 2016-02-23 | 30-day Notice |
| S082 | 2015-12-28 | 30-day Notice |
| S081 | 2015-12-15 | 30-day Notice |
| S080 | 2015-11-27 | 30-day Notice |
| S079 | 2015-11-09 | 30-day Notice |
| S078 | 2015-11-09 | 30-day Notice |
| S077 | 2015-11-09 | 30-day Notice |
| S076 | 2015-11-03 | 135 Review Track For 30-day Notice |
| S075 | 2015-11-03 | 30-day Notice |
| S074 | 2015-11-02 | Real-time Process |
| S073 | 2015-10-19 | 30-day Notice |
| S072 | 2015-08-10 | 135 Review Track For 30-day Notice |
| S071 | 2015-07-20 | Normal 180 Day Track No User Fee |
| S070 | 2015-06-09 | Normal 180 Day Track |
| S069 | 2015-05-29 | 30-day Notice |
| S068 | 2015-05-01 | 135 Review Track For 30-day Notice |
| S067 | 2015-04-29 | Real-time Process |
| S066 | 2015-04-20 | 30-day Notice |
| S065 | 2015-03-18 | 30-day Notice |
| S064 | 2015-03-10 | 135 Review Track For 30-day Notice |
| S063 | 2015-02-26 | 30-day Notice |
| S062 | 2015-02-18 | Real-time Process |
| S061 | 2015-02-06 | Real-time Process |
| S060 | 2015-01-30 | 30-day Notice |
| S059 | 2015-01-28 | 30-day Notice |
| S058 | 2015-01-26 | 135 Review Track For 30-day Notice |
| S057 | 2015-01-26 | 30-day Notice |
| S056 | 2015-01-06 | Real-time Process |
| S055 | 2014-12-31 | 30-day Notice |
| S054 | 2014-12-30 | Real-time Process |
| S053 | 2014-12-30 | 30-day Notice |
| S052 | 2015-02-17 | Normal 180 Day Track |
| S051 | 2014-12-15 | 30-day Notice |
| S050 | 2014-12-10 | 30-day Notice |
| S049 | 2014-12-04 | 30-day Notice |
| S048 | 2014-12-02 | 30-day Notice |
| S047 | 2014-11-26 | 30-day Notice |
| S046 | 2014-12-10 | Panel Track |
| S045 | 2014-11-04 | 30-day Notice |
| S044 | ||
| S043 | 2014-11-03 | 30-day Notice |
| S042 | 2014-10-31 | Real-time Process |
| S041 | 2014-10-30 | Real-time Process |
| S040 | 2014-10-30 | 135 Review Track For 30-day Notice |
| S039 | 2014-10-27 | 30-day Notice |
| S038 | 2014-10-22 | 30-day Notice |
| S037 | 2014-10-20 | 30-day Notice |
| S036 | 2014-09-22 | Real-time Process |
| S035 | 2014-09-05 | 30-day Notice |
| S034 | 2014-09-04 | 30-day Notice |
| S033 | 2014-08-11 | 135 Review Track For 30-day Notice |
| S032 | 2014-08-01 | Normal 180 Day Track No User Fee |
| S031 | 2014-07-29 | 30-day Notice |
| S030 | 2014-07-07 | Real-time Process |
| S029 | 2014-07-11 | Normal 180 Day Track |
| S028 | 2014-06-24 | 30-day Notice |
| S027 | 2014-06-23 | 30-day Notice |
| S026 | 2014-06-23 | Real-time Process |
| S025 | 2014-06-03 | 30-day Notice |
| S024 | 2014-06-02 | Real-time Process |
| S023 | 2014-04-29 | 135 Review Track For 30-day Notice |
| S022 | 2014-04-14 | 30-day Notice |
| S021 | 2014-04-11 | Real-time Process |
| S020 | 2014-04-11 | 30-day Notice |
| S019 | 2014-03-21 | Real-time Process |
| S018 | ||
| S017 | 2014-03-10 | 30-day Notice |
| S016 | 2014-03-06 | Real-time Process |
| S015 | 2014-03-04 | 30-day Notice |
| S014 | 2014-03-04 | 30-day Notice |
| S013 | 2014-02-24 | 30-day Notice |
| S012 | 2014-02-20 | 30-day Notice |
| S011 | 2014-02-18 | 30-day Notice |
| S010 | 2014-02-06 | 30-day Notice |
| S009 | 2014-01-28 | 30-day Notice |
| S008 | 2013-12-23 | Real-time Process |
| S007 | ||
| S006 | 2013-11-08 | 30-day Notice |
| S005 | 2013-11-08 | 135 Review Track For 30-day Notice |
| S004 | 2013-11-08 | 135 Review Track For 30-day Notice |
| S003 | 2013-11-07 | 135 Review Track For 30-day Notice |
| S002 | 2013-11-07 | Special (immediate Track) |
| S001 | 2013-11-06 | 135 Review Track For 30-day Notice |