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 of an alternate eo sterilization cycle and upgraded sterilization equipment to sterilize all sterile products and accessories of the dbs systems, except for the burr hole cover kit.
| Device | Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems |
| Generic Name | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms |
| Applicant | Boston Scientific Corp. |
| Date Received | 2020-02-20 |
| Decision Date | 2020-03-17 |
| PMA | P150031 |
| Supplement | S029 |
| Product Code | NHL |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |