Approval for the brio neurostimulation system. This device is indicated for the following conditions:1) bilateral stimulation of the subthalamic nucleus (stn) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive parkinsons disease that are not adequately controlled by medications; and 2) unilateral or bilateral stimulation of the ventral intermediate nucleus (vim) of the thalamus for the suppression of disabling upper extremity tremor in adult essentialtremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability.
| Device | BRIO NEUROSTIMULATION SYSTEM |
| Classification Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
| Generic Name | Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
| Applicant | Abbott Medical |
| Date Received | 2014-05-05 |
| Decision Date | 2015-06-12 |
| Notice Date | 2015-07-10 |
| PMA | P140009 |
| Supplement | S |
| Product Code | MHY |
| Docket Number | 15M-2497 |
| Advisory Committee | Neurology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 6901 Prestion Road plano, TX 75024 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140009 | | Original Filing |
| S080 |
2022-09-29 |
30-day Notice |
| S079 |
2022-09-21 |
30-day Notice |
| S078 |
2022-06-02 |
30-day Notice |
| S077 | | |
| S076 |
2022-02-22 |
30-day Notice |
| S075 |
2022-01-18 |
30-day Notice |
| S074 |
2021-10-22 |
Real-time Process |
| S073 | | |
| S072 |
2021-07-01 |
30-day Notice |
| S071 | | |
| S070 |
2021-06-15 |
Special (immediate Track) |
| S069 |
2021-05-10 |
30-day Notice |
| S068 |
2021-03-25 |
30-day Notice |
| S067 | | |
| S066 |
2021-02-08 |
30-day Notice |
| S065 |
2020-10-28 |
135 Review Track For 30-day Notice |
| S064 |
2020-09-09 |
Normal 180 Day Track |
| S063 |
2020-07-27 |
Real-time Process |
| S062 | | |
| S061 |
2020-07-13 |
Special (immediate Track) |
| S060 |
2020-05-07 |
30-day Notice |
| S059 |
2020-04-30 |
30-day Notice |
| S058 | | |
| S057 |
2020-04-06 |
30-day Notice |
| S056 |
2020-04-06 |
30-day Notice |
| S055 |
2020-02-03 |
30-day Notice |
| S054 |
2019-12-13 |
30-day Notice |
| S053 | | |
| S052 | | |
| S051 |
2019-10-21 |
30-day Notice |
| S050 |
2019-08-09 |
Special (immediate Track) |
| S049 | | |
| S048 |
2019-07-01 |
30-day Notice |
| S047 |
2019-05-07 |
Normal 180 Day Track No User Fee |
| S046 | | |
| S045 |
2019-02-01 |
30-day Notice |
| S044 |
2018-12-17 |
30-day Notice |
| S043 |
2018-11-08 |
30-day Notice |
| S042 |
2018-10-19 |
30-day Notice |
| S041 |
2018-10-18 |
Special (immediate Track) |
| S040 |
2018-09-06 |
30-day Notice |
| S039 | | |
| S038 |
2018-05-04 |
135 Review Track For 30-day Notice |
| S037 |
2018-02-13 |
Normal 180 Day Track |
| S036 |
2018-02-02 |
135 Review Track For 30-day Notice |
| S035 |
2017-12-18 |
30-day Notice |
| S034 |
2017-12-15 |
Real-time Process |
| S033 |
2017-12-15 |
30-day Notice |
| S032 |
2017-11-16 |
30-day Notice |
| S031 |
2017-11-13 |
30-day Notice |
| S030 |
2017-09-11 |
Real-time Process |
| S029 |
2017-09-08 |
30-day Notice |
| S028 |
2017-08-10 |
30-day Notice |
| S027 |
2017-07-28 |
Normal 180 Day Track No User Fee |
| S026 | | |
| S025 |
2017-06-26 |
30-day Notice |
| S024 |
2017-06-02 |
30-day Notice |
| S023 |
2017-02-14 |
Real-time Process |
| S022 |
2016-11-07 |
Normal 180 Day Track |
| S021 |
2016-11-01 |
30-day Notice |
| S020 |
2016-10-11 |
Real-time Process |
| S019 |
2016-07-11 |
Real-time Process |
| S018 | | |
| S017 |
2016-06-22 |
Real-time Process |
| S016 |
2016-06-13 |
30-day Notice |
| S015 |
2016-06-06 |
Normal 180 Day Track |
| S014 |
2016-04-28 |
30-day Notice |
| S013 |
2016-03-21 |
30-day Notice |
| S012 |
2016-02-02 |
30-day Notice |
| S011 |
2016-01-27 |
30-day Notice |
| S010 |
2015-12-11 |
Normal 180 Day Track |
| S009 |
2015-11-09 |
30-day Notice |
| S008 |
2015-11-06 |
30-day Notice |
| S007 |
2015-10-08 |
30-day Notice |
| S006 |
2015-10-07 |
30-day Notice |
| S005 |
2015-09-21 |
Real-time Process |
| S004 |
2015-08-21 |
Normal 180 Day Track No User Fee |
| S003 |
2015-08-14 |
30-day Notice |
| S002 |
2015-08-04 |
Real-time Process |
| S001 |
2015-07-02 |
Normal 180 Day Track |
NIH GUDID Devices