This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the algovita spinal cord stimulation system. This device is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
| Device | ALGOVITA SPINAL CORD STIMULATION SYSTEM |
| Classification Name | Stimulator, Spinal-cord, Totally Implanted For Pain Relief |
| Generic Name | Stimulator, Spinal-cord, Totally Implanted For Pain Relief |
| Applicant | Nuvectra Corporation |
| Date Received | 2013-12-16 |
| Decision Date | 2015-11-20 |
| Notice Date | 2015-11-30 |
| PMA | P130028 |
| Supplement | S |
| Product Code | LGW |
| Docket Number | 15M-4434 |
| Advisory Committee | Neurology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Nuvectra Corporation 10675 Naples Street Ne blaine, MN 55449 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| 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 |