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 to use vlsip technologies as an alternate supplier for the ball grid array (bga), an electronic component on the printed circuit board assembly (pcba) of the implantable pulse generators (ipg) and external trial stimulators (ets) of the wavewriter alpha spinal cord stimulator (scs) system and vercise genus deep brain stimulation (dbs) system.
| Device | Vercise Genus™ Deep Brain Stimulation (DBS) System |
| Generic Name | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms |
| Applicant | Boston Scientific Corp. |
| Date Received | 2021-10-12 |
| Decision Date | 2021-11-10 |
| PMA | P150031 |
| Supplement | S046 |
| 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 |