For the addition of an alternate laser welder, the ipg laser weld system, to perform laser welding on the rns neurostimulator during manufacturing operations at neuropace (455 n. Bernardo ave. Mountain, ca 94043)
| Device | NeuroPac RNS System |
| Classification Name | Implanted Brain Stimulator For Epilepsy |
| Generic Name | Implanted Brain Stimulator For Epilepsy |
| Applicant | NEUROPACE INC |
| Date Received | 2019-08-15 |
| Decision Date | 2019-08-26 |
| PMA | P100026 |
| Supplement | S074 |
| 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