To make manufacturing process changes to printed circuit assembly, interlay, and top can barrier tape for the rns neurostimulator, model 320
| Device | NeuroPace RNS System |
| Classification Name | Implanted Brain Stimulator For Epilepsy |
| Generic Name | Implanted Brain Stimulator For Epilepsy |
| Applicant | NEUROPACE INC |
| Date Received | 2019-10-28 |
| Decision Date | 2019-11-05 |
| PMA | P100026 |
| Supplement | S076 |
| 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