Approval for the current neuropace supplier of the tunneling tool straw (straw), teleflex medical oem (located at 50 plantation drive, jaffrey nh 03452), to source raw polytetrafluoroethylene (ptfe) resin used in the straw manufacture from an alternate supplier.
| Device | NeuroPace RNS System |
| Classification Name | Implanted Brain Stimulator For Epilepsy |
| Generic Name | Implanted Brain Stimulator For Epilepsy |
| Applicant | NEUROPACE INC |
| Date Received | 2019-02-06 |
| Decision Date | 2019-09-19 |
| PMA | P100026 |
| Supplement | S063 |
| Product Code | PFN |
| Advisory Committee | Neurology |
| Supplement Type | 135 Review Track For 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