Approval to modify the pxi vader automated test equipment (ate) software to improve yield of the components used to manufacture the rns® neurostimulator (model rns-320) during the custom packaged integrated circuit (cassandra) and printed circuit assembly (pca) testing. In addition, this submission includes an update to pxi vader ate software for final electrical test to support future product changes currently under development
| Device | NeuroPace RNS System |
| Classification Name | Implanted Brain Stimulator For Epilepsy |
| Generic Name | Implanted Brain Stimulator For Epilepsy |
| Applicant | NEUROPACE INC |
| Date Received | 2019-08-02 |
| Decision Date | 2019-08-08 |
| PMA | P100026 |
| Supplement | S073 |
| Product Code | PFN |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NEUROPACE INC 455 N. Bernardo Ave mountain View, CA 94043 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100026 | | Original Filing |
| S091 |
2022-09-26 |
Normal 180 Day Track No User Fee |
| S090 |
2022-04-29 |
Real-time Process |
| S089 |
2021-11-24 |
30-day Notice |
| S088 | | |
| S087 | | |
| S086 |
2021-05-04 |
30-day Notice |
| S085 | | |
| S084 |
2020-08-14 |
Normal 180 Day Track No User Fee |
| S083 |
2020-07-10 |
30-day Notice |
| S082 | | |
| S081 |
2020-04-16 |
Real-time Process |
| S080 |
2020-04-01 |
30-day Notice |
| S079 |
2020-03-17 |
30-day Notice |
| S078 |
2020-01-16 |
30-day Notice |
| S077 | | |
| S076 |
2019-10-28 |
30-day Notice |
| S075 | | |
| S074 |
2019-08-15 |
30-day Notice |
| S073 |
2019-08-02 |
30-day Notice |
| S072 |
2019-06-20 |
30-day Notice |
| S071 |
2019-06-10 |
30-day Notice |
| S070 | | |
| S069 | | |
| S068 |
2019-05-21 |
30-day Notice |
| S067 |
2019-04-24 |
30-day Notice |
| S066 | | |
| S065 |
2019-03-11 |
Special (immediate Track) |
| S064 | | |
| S063 |
2019-02-06 |
135 Review Track For 30-day Notice |
| S062 | | |
| S061 |
2018-11-23 |
30-day Notice |
| S060 |
2018-10-03 |
30-day Notice |
| S059 |
2018-09-04 |
30-day Notice |
| S058 |
2018-08-09 |
30-day Notice |
| S057 |
2018-07-16 |
30-day Notice |
| S056 |
2018-07-03 |
30-day Notice |
| S055 | | |
| S054 |
2018-02-20 |
Real-time Process |
| S053 |
2018-01-25 |
30-day Notice |
| S052 |
2017-12-12 |
30-day Notice |
| S051 |
2017-12-11 |
30-day Notice |
| S050 |
2017-09-20 |
Real-time Process |
| S049 |
2017-04-19 |
30-day Notice |
| S048 |
2017-03-08 |
30-day Notice |
| S047 |
2017-02-15 |
Normal 180 Day Track |
| S046 |
2016-11-15 |
30-day Notice |
| S045 |
2016-11-10 |
30-day Notice |
| S044 |
2016-10-17 |
30-day Notice |
| S043 |
2016-04-29 |
Real-time Process |
| S042 |
2016-02-03 |
30-day Notice |
| S041 |
2016-01-07 |
30-day Notice |
| S040 |
2015-12-16 |
Normal 180 Day Track |
| S039 |
2015-11-09 |
30-day Notice |
| S038 |
2015-10-06 |
30-day Notice |
| S037 |
2015-06-25 |
30-day Notice |
| S036 |
2015-06-16 |
Normal 180 Day Track |
| S035 |
2015-05-15 |
30-day Notice |
| S034 |
2015-05-06 |
Normal 180 Day Track No User Fee |
| S033 |
2015-05-05 |
Normal 180 Day Track No User Fee |
| S032 |
2015-04-14 |
135 Review Track For 30-day Notice |
| S031 |
2015-03-10 |
30-day Notice |
| S030 |
2015-02-06 |
30-day Notice |
| S029 |
2015-01-20 |
30-day Notice |
| S028 |
2015-01-13 |
Real-time Process |
| S027 |
2014-12-19 |
30-day Notice |
| S026 |
2014-12-18 |
Real-time Process |
| S025 |
2014-11-26 |
30-day Notice |
| S024 |
2014-07-24 |
30-day Notice |
| S023 |
2014-07-22 |
30-day Notice |
| S022 |
2014-07-09 |
Normal 180 Day Track No User Fee |
| S021 |
2014-06-19 |
Normal 180 Day Track No User Fee |
| S020 |
2014-06-18 |
Normal 180 Day Track No User Fee |
| S019 |
2014-06-09 |
30-day Notice |
| S018 |
2014-05-19 |
30-day Notice |
| S017 |
2014-04-10 |
Real-time Process |
| S016 |
2014-04-02 |
30-day Notice |
| S015 |
2014-03-18 |
30-day Notice |
| S014 |
2014-03-07 |
30-day Notice |
| S013 |
2014-02-21 |
30-day Notice |
| S012 | | |
| S011 |
2014-02-12 |
Real-time Process |
| S010 |
2014-01-28 |
30-day Notice |
| S009 |
2014-01-24 |
30-day Notice |
| S008 |
2014-01-17 |
30-day Notice |
| S007 |
2013-12-23 |
30-day Notice |
| S006 |
2013-12-16 |
Normal 180 Day Track No User Fee |
| S005 |
2013-12-13 |
Normal 180 Day Track No User Fee |
| S004 |
2013-12-12 |
Normal 180 Day Track No User Fee |
| S003 |
2013-12-11 |
Normal 180 Day Track No User Fee |
| S002 |
2013-11-21 |
30-day Notice |
| S001 |
2013-11-18 |
30-day Notice |
NIH GUDID Devices