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 use for the algovita clinician programmer application and nuvectra bridge communicator as per the letter dated may 5, 2020.
| Device | Algovita Spinal Cord Stimulation System |
| Generic Name | Stimulator, Spinal-cord, Totally Implanted For Pain Relief |
| Applicant | Nuvectra Corporation |
| Date Received | 2019-11-05 |
| Decision Date | 2020-05-05 |
| PMA | P130028 |
| Supplement | S031 |
| Product Code | LGW |
| Advisory Committee | Neurology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Nuvectra Corporation 10675 Naples Street Ne blaine, MN 55449 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130028 | Original Filing | |
| S031 | 2019-11-05 | Normal 180 Day Track |
| S030 | 2019-09-27 | 30-day Notice |
| S029 | 2019-08-28 | 30-day Notice |
| S028 | ||
| S027 | 2019-07-29 | 30-day Notice |
| S026 | 2019-07-12 | 30-day Notice |
| S025 | ||
| S024 | 2019-06-05 | 30-day Notice |
| S023 | 2019-05-02 | 30-day Notice |
| S022 | 2018-06-22 | Real-time Process |
| S021 | 2018-05-29 | 30-day Notice |
| S020 | 2018-02-20 | Real-time Process |
| S019 | ||
| S018 | 2017-06-12 | Normal 180 Day Track |
| S017 | 2017-05-08 | 30-day Notice |
| S016 | 2017-03-02 | 30-day Notice |
| S015 | 2017-02-28 | 30-day Notice |
| S014 | 2017-02-17 | Real-time Process |
| S013 | 2017-01-13 | Special (immediate Track) |
| S012 | 2016-07-22 | 30-day Notice |
| S011 | 2016-07-13 | 30-day Notice |
| S010 | 2016-06-16 | 30-day Notice |
| S009 | 2016-05-27 | Real-time Process |
| S008 | 2016-05-24 | 30-day Notice |
| S007 | 2016-04-29 | 30-day Notice |
| S006 | 2016-04-13 | 30-day Notice |
| S005 | 2016-03-14 | Real-time Process |
| S004 | 2016-03-14 | Real-time Process |
| S003 | 2016-02-18 | 30-day Notice |
| S002 | 2016-01-19 | 30-day Notice |
| S001 | 2015-11-27 | 30-day Notice |