NeuroPace RNS System

FDA Premarket Approval P100026 S090

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.

Pre-market Approval Supplement Details

DeviceNeuroPace RNS System
Generic NameImplanted Brain Stimulator For Epilepsy
ApplicantNEUROPACE INC455 N. Bernardo Avemountain View, CA 94043 PMA NumberP100026 Supplement NumberS090 Date Received04/29/2022 Decision Date07/28/2022 Product Code PFN  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-04-29
Decision Date2022-07-28
PMAP100026
SupplementS090
Product CodePFN 
Advisory CommitteeNeurology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressNEUROPACE INC
455 N. Bernardo Ave
mountain View, CA 94043 PMA NumberP100026 Supplement NumberS090 Date Received04/29/2022 Decision Date07/28/2022 Product Code PFN  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For Updates And Improvements To The Currently Approved RNS® Tablet Programmer Application Software And Related Change To The NeuroPace® Patient Data Management System Application Software, Along With Related Labeling Updates.

Supplemental Filings

Supplement NumberDateSupplement Type
P100026Original Filing
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

Device IDPMASupp
00855547005274 P100026 000
00855547005021 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
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
00855547005410 P100026 000

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.