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 the cartesia deep brain stimulation directional lead.
| Device | Vercise PC/Gevia DBS System |
| Classification Name | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms |
| Generic Name | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms |
| Applicant | Boston Scientific Corp. |
| Date Received | 2017-12-22 |
| Decision Date | 2019-01-18 |
| PMA | P150031 |
| Supplement | S002 |
| Product Code | NHL |
| Advisory Committee | Neurology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. 25155 Rye Canyon Loop valencia, CA 91355 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150031 | Original Filing | |
| S054 | 2022-12-08 | 30-day Notice |
| S053 | 2022-12-07 | 30-day Notice |
| S052 | ||
| S051 | 2022-11-14 | 30-day Notice |
| S050 | 2022-06-13 | 30-day Notice |
| S049 | ||
| S048 | 2022-01-10 | Real-time Process |
| S047 | 2021-11-15 | 30-day Notice |
| S046 | 2021-10-12 | 30-day Notice |
| S045 | ||
| S044 | 2021-09-13 | 30-day Notice |
| S043 | 2021-05-24 | 30-day Notice |
| S042 | 2021-05-07 | 30-day Notice |
| S041 | 2021-04-19 | 30-day Notice |
| S040 | ||
| S039 | ||
| S038 | 2020-07-23 | 30-day Notice |
| S037 | 2020-07-13 | 30-day Notice |
| S036 | 2020-07-13 | Special (immediate Track) |
| S035 | 2020-05-22 | 30-day Notice |
| S034 | ||
| S033 | 2020-04-20 | 30-day Notice |
| S032 | 2020-04-17 | 30-day Notice |
| S031 | ||
| S030 | 2020-03-27 | 30-day Notice |
| S029 | 2020-02-20 | 30-day Notice |
| S028 | ||
| S027 | 2019-11-06 | 30-day Notice |
| S026 | ||
| S025 | ||
| S024 | 2019-08-26 | 30-day Notice |
| S023 | 2019-08-16 | 30-day Notice |
| S022 | 2019-08-05 | Special (immediate Track) |
| S021 | ||
| S020 | 2019-05-08 | 30-day Notice |
| S019 | 2019-04-03 | 30-day Notice |
| S018 | 2019-04-03 | 30-day Notice |
| S017 | 2019-03-12 | 30-day Notice |
| S016 | ||
| S015 | 2019-02-19 | 30-day Notice |
| S014 | 2019-02-13 | 30-day Notice |
| S013 | 2019-02-12 | 30-day Notice |
| S012 | 2019-01-31 | 30-day Notice |
| S011 | ||
| S010 | 2018-10-29 | 30-day Notice |
| S009 | ||
| S008 | 2018-07-23 | 30-day Notice |
| S007 | 2018-07-11 | 30-day Notice |
| S006 | 2018-05-21 | 30-day Notice |
| S005 | 2018-02-22 | Normal 180 Day Track |
| S004 | ||
| S003 | 2018-01-17 | Normal 180 Day Track No User Fee |
| S002 | 2017-12-22 | Normal 180 Day Track |
| S001 | 2017-12-21 | Normal 180 Day Track |