Approval to add an existing neuropace supplier as an alternate supplier to manufacture the peek connector cover part of the connector cover assemblies and connector cover kits for the rns neurostimulators (model rns-320 and rns-300m) and to manufacture this part by injection molding rather than by the current machining process.
| Device | NeuroPace® RNS® System |
| Generic Name | Implanted Brain Stimulator For Epilepsy |
| Applicant | NEUROPACE INC |
| Date Received | 2021-11-24 |
| Decision Date | 2021-12-16 |
| PMA | P100026 |
| Supplement | S089 |
| 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