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 updates to the labeling with the results of the extended follow up of the premarket cohort post approval study.
| Device | Inspire Upper Airway Stimulation Therapy |
| Classification Name | Stimulator, Hypoglossal Nerve, Implanted, Apnea |
| Generic Name | Stimulator, Hypoglossal Nerve, Implanted, Apnea |
| Applicant | INSPIRE MEDICAL SYSTEMS |
| Date Received | 2017-11-14 |
| Decision Date | 2018-05-11 |
| PMA | P130008 |
| Supplement | S029 |
| Product Code | MNQ |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INSPIRE MEDICAL SYSTEMS 9700 63rd Avenue North suite 200 maple Grove, MN 55369 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130008 | Original Filing | |
| S093 | 2022-11-18 | Normal 180 Day Track No User Fee |
| S092 | ||
| S091 | ||
| S090 | ||
| S089 | ||
| S088 | 2022-07-29 | 30-day Notice |
| S087 | ||
| S086 | ||
| S085 | ||
| S084 | 2022-05-20 | 30-day Notice |
| S083 | 2022-03-15 | 30-day Notice |
| S082 | 2022-03-02 | 30-day Notice |
| S081 | 2022-02-17 | 30-day Notice |
| S080 | 2022-02-17 | 30-day Notice |
| S079 | 2022-02-11 | 30-day Notice |
| S078 | 2022-01-26 | 30-day Notice |
| S077 | 2022-01-05 | 30-day Notice |
| S076 | ||
| S075 | 2021-10-07 | 30-day Notice |
| S074 | ||
| S073 | 2021-08-13 | Normal 180 Day Track No User Fee |
| S072 | ||
| S071 | 2021-07-13 | 30-day Notice |
| S070 | ||
| S069 | ||
| S068 | ||
| S067 | 2021-05-25 | 30-day Notice |
| S066 | 2021-05-14 | 30-day Notice |
| S065 | ||
| S064 | 2021-03-12 | 30-day Notice |
| S063 | 2020-12-14 | Normal 180 Day Track |
| S062 | 2020-09-14 | 30-day Notice |
| S061 | ||
| S060 | 2020-08-31 | 30-day Notice |
| S059 | 2020-08-26 | 30-day Notice |
| S058 | 2020-08-20 | 30-day Notice |
| S057 | ||
| S056 | ||
| S055 | ||
| S054 | 2020-06-25 | 30-day Notice |
| S053 | 2020-05-19 | 30-day Notice |
| S052 | 2020-05-14 | Normal 180 Day Track No User Fee |
| S051 | 2020-01-31 | 30-day Notice |
| S050 | ||
| S049 | 2019-12-17 | Special (immediate Track) |
| S048 | 2019-12-12 | 30-day Notice |
| S047 | ||
| S046 | 2019-08-16 | 30-day Notice |
| S045 | 2019-06-24 | 30-day Notice |
| S044 | 2019-05-23 | 30-day Notice |
| S043 | ||
| S042 | ||
| S041 | 2019-04-23 | Real-time Process |
| S040 | 2019-01-29 | 30-day Notice |
| S039 | ||
| S038 | 2018-12-11 | 30-day Notice |
| S037 | 2018-10-26 | Real-time Process |
| S036 | 2018-10-15 | 30-day Notice |
| S035 | 2018-08-16 | 30-day Notice |
| S034 | 2018-04-16 | Normal 180 Day Track |
| S033 | 2018-02-14 | Real-time Process |
| S032 | 2018-02-05 | 30-day Notice |
| S031 | 2017-12-13 | Normal 180 Day Track |
| S030 | ||
| S029 | 2017-11-14 | Normal 180 Day Track No User Fee |
| S028 | 2017-11-08 | 30-day Notice |
| S027 | 2017-10-13 | 30-day Notice |
| S026 | 2017-05-09 | 30-day Notice |
| S025 | 2017-05-08 | 30-day Notice |
| S024 | 2017-05-08 | 30-day Notice |
| S023 | 2017-05-04 | Real-time Process |
| S022 | 2017-03-29 | Normal 180 Day Track No User Fee |
| S021 | 2017-03-29 | Normal 180 Day Track |
| S020 | 2017-01-23 | Normal 180 Day Track |
| S019 | 2016-12-08 | 30-day Notice |
| S018 | 2016-11-23 | 30-day Notice |
| S017 | 2016-11-17 | 30-day Notice |
| S016 | 2016-10-06 | Normal 180 Day Track |
| S015 | 2016-09-14 | 30-day Notice |
| S014 | 2016-07-05 | 30-day Notice |
| S013 | 2016-05-05 | Normal 180 Day Track |
| S012 | 2016-04-22 | 30-day Notice |
| S011 | 2016-04-08 | 30-day Notice |
| S010 | 2016-03-30 | Normal 180 Day Track No User Fee |
| S009 | 2015-11-12 | Normal 180 Day Track |
| S008 | 2015-05-27 | Real-time Process |
| S007 | 2015-03-25 | 30-day Notice |
| S006 | 2015-03-03 | 30-day Notice |
| S005 | 2015-01-28 | 30-day Notice |
| S004 | 2014-10-07 | 30-day Notice |
| S003 | 2014-07-23 | Normal 180 Day Track No User Fee |
| S002 | 2014-06-30 | Normal 180 Day Track |
| S001 | 2014-05-12 | 30-day Notice |