NeuroPace RNS System

Implanted Brain Stimulator For Epilepsy

FDA Premarket Approval P100026 S076

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

To make manufacturing process changes to printed circuit assembly, interlay, and top can barrier tape for the rns neurostimulator, model 320

DeviceNeuroPace RNS System
Classification NameImplanted Brain Stimulator For Epilepsy
Generic NameImplanted Brain Stimulator For Epilepsy
ApplicantNEUROPACE INC
Date Received2019-10-28
Decision Date2019-11-05
PMAP100026
SupplementS076
Product CodePFN
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address NEUROPACE INC 455 N. Bernardo Ave mountain View, CA 94043

Supplemental Filings

Supplement NumberDateSupplement Type
P100026Original Filing
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
00855547005199 P100026 000
00855547005076 P100026 000
00855547005069 P100026 000
00855547005052 P100026 000
00855547005045 P100026 000
00855547005038 P100026 000
00855547005021 P100026 000
00855547005014 P100026 000
00855547005182 P100026 000
00855547005212 P100026 000
00855547005113 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
00855547005007 P100026 000

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