NEUROPACE RNS SYSTEM

Implanted Brain Stimulator For Epilepsy

FDA Premarket Approval P100026 S006

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

Approval of the post-approval study protocol.

DeviceNEUROPACE RNS SYSTEM
Classification NameImplanted Brain Stimulator For Epilepsy
Generic NameImplanted Brain Stimulator For Epilepsy
ApplicantNEUROPACE INC
Date Received2013-12-16
Decision Date2014-02-14
PMAP100026
SupplementS006
Product CodePFN
Advisory CommitteeNeurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Osb
Expedited ReviewNo
Combination Product No
Applicant Address NEUROPACE INC 455 N. Bernardo Ave mountain View, CA 94043

Supplemental Filings

Supplement NumberDateSupplement Type
P100026Original 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

Device IDPMASupp
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00855547005434 P100026 000

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