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.
| Device | NeuroPace® RNS® System |
| Generic Name | Implanted Brain Stimulator For Epilepsy |
| Applicant | NEUROPACE INC455 N. Bernardo Avemountain View, CA 94043 PMA NumberP100026 Supplement NumberS091 Date Received09/26/2022 Decision Date12/29/2022 Product Code PFN Advisory Committee Neurology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-26 |
| Decision Date | 2022-12-29 |
| PMA | P100026 |
| Supplement | S091 |
| Product Code | PFN |
| Advisory Committee | Neurology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NEUROPACE INC 455 N. Bernardo Ave mountain View, CA 94043 PMA NumberP100026 Supplement NumberS091 Date Received09/26/2022 Decision Date12/29/2022 Product Code PFN Advisory Committee Neurology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Use A Second Contract Sterilizer For The Ethylene Oxide (EO) Sterilization Of RNS System Products |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00855547005274 | P100026 | 000 |
| 00855547005014 | P100026 | 000 |
| 00855547005007 | P100026 | 000 |
| 00855547005366 | P100026 | 000 |
| 00855547005359 | P100026 | 000 |
| 00855547005342 | P100026 | 000 |
| 00855547005335 | P100026 | 000 |
| 00855547005328 | P100026 | 000 |
| 00855547005311 | P100026 | 000 |
| 00855547005304 | P100026 | 000 |
| 00855547005298 | P100026 | 000 |
| 00855547005397 | P100026 | 000 |
| 00855547005380 | P100026 | 000 |
| 00855547005373 | P100026 | 000 |
| 00855547005403 | P100026 | 000 |
| 00855547005410 | P100026 | 000 |
| 00855547005021 | P100026 | 000 |
| 00855547005038 | P100026 | 000 |
| 00855547005045 | P100026 | 000 |
| 00855547005267 | P100026 | 000 |
| 00855547005243 | P100026 | 000 |
| 00855547005229 | P100026 | 000 |
| 00855547005175 | P100026 | 000 |
| 00855547005168 | P100026 | 000 |
| 00855547005151 | P100026 | 000 |
| 00855547005137 | P100026 | 000 |
| 00855547005120 | P100026 | 000 |
| 00855547005113 | P100026 | 000 |
| 00855547005212 | P100026 | 000 |
| 00855547005182 | P100026 | 000 |
| 00855547005199 | P100026 | 000 |
| 00855547005076 | P100026 | 000 |
| 00855547005069 | P100026 | 000 |
| 00855547005052 | P100026 | 000 |
| 00855547005434 | P100026 | 000 |