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.
Changes to incorporate several process enhancements to the distal final bond and distal epoxy backfill manufacturing processes for the percutaneous leads and trial leads. The changes do not change the design of the leads
| Device | Algovita Spinal Cord Stimulation System (SCS), Trial Lead: 8/12 Electrode Percutaneous Lead Kit |
| 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 | 2018-05-29 |
| Decision Date | 2018-06-28 |
| PMA | P130028 |
| Supplement | S021 |
| Product Code | LGW |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |