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.
Process changes to the manufacture of the spinal cord stimulator system battery charger, including the addition of an adhesive to a component on the printed circuit board (pcb), minor alterations to the pcb layout to improve manufacturability, and the addition of torque wrenches to its manufacturing process.
| 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 | 2016-03-16 |
| Decision Date | 2016-04-15 |
| PMA | P130022 |
| Supplement | S006 |
| 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 |