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.
Packaging configuration change (i. E. , pre-loaded percutaneous lead with the 0. 014” curved stylet) to the senza scs system.
| Device | NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM |
| Classification Name | Stimulator, Spinal-cord, Totally Implanted For Pain Relief |
| Generic Name | Stimulator, Spinal-cord, Totally Implanted For Pain Relief |
| Applicant | NEVRO CORPORATION |
| Date Received | 2016-12-19 |
| Decision Date | 2017-01-17 |
| PMA | P130022 |
| Supplement | S011 |
| 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 | NEVRO CORPORATION 1800 Bridge Parkway redwood City, CA 94065 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130022 | Original Filing | |
| S047 | 2022-11-22 | 30-day Notice |
| S046 | 2022-04-15 | Special (immediate Track) |
| S045 | ||
| S044 | ||
| S043 | ||
| S042 | 2021-07-22 | Panel Track |
| S041 | 2021-02-12 | Real-time Process |
| S040 | 2021-02-09 | Normal 180 Day Track |
| S039 | ||
| S038 | 2020-11-09 | Real-time Process |
| S037 | ||
| S036 | ||
| S035 | ||
| S034 | ||
| S033 | 2020-04-27 | Special (immediate Track) |
| S032 | ||
| S031 | 2020-01-03 | Real-time Process |
| S030 | ||
| S029 | ||
| S028 | 2019-08-12 | Normal 180 Day Track |
| S027 | 2019-08-12 | Real-time Process |
| S026 | 2019-07-29 | Real-time Process |
| S025 | 2019-05-24 | Real-time Process |
| S024 | ||
| S023 | 2019-04-19 | Real-time Process |
| S022 | ||
| S021 | ||
| S020 | ||
| S019 | 2018-08-13 | Normal 180 Day Track |
| S018 | 2018-07-23 | Real-time Process |
| S017 | 2017-09-12 | Normal 180 Day Track No User Fee |
| S016 | 2017-09-06 | 30-day Notice |
| S015 | 2017-07-14 | 30-day Notice |
| S014 | 2017-07-03 | Normal 180 Day Track |
| S013 | 2017-05-16 | Normal 180 Day Track |
| S012 | 2017-02-01 | 30-day Notice |
| S011 | 2016-12-19 | 30-day Notice |
| S010 | 2016-10-20 | Normal 180 Day Track No User Fee |
| S009 | 2016-09-26 | Real-time Process |
| S008 | 2016-05-02 | Real-time Process |
| S007 | 2016-04-11 | 135 Review Track For 30-day Notice |
| S006 | 2016-03-16 | 30-day Notice |
| S005 | 2016-03-16 | Real-time Process |
| S004 | 2015-11-23 | Normal 180 Day Track |
| S003 | ||
| S002 | 2015-09-04 | Real-time Process |
| S001 | 2015-09-02 | 30-day Notice |