FDA.reportPublic FDA data

PMA P100026S085

Device
Neuropace RNS System
Applicant
NeuroPace, Inc.
Product code
PFN
Decision date
2021-05-24
Generic name
Implanted brain stimulator for epilepsy
Approval order statement
Approval for minor updates to the RNS® Tablet. NeuroPace is requesting approval for addition of Mobile Device Management (MDM) capability on the tablet platform as well as changes to the login requirements for accessing the NeuroPace Programmer Application on the tablet.

Current openFDA PMA Record#

Device
Neuropace RNS System
Applicant
NeuroPace, Inc.
PMA number
P100026
Supplement
S085
Product code
PFN
Generic name
Implanted brain stimulator for epilepsy
Decision date
2021-05-24
Decision code
APPR
Date received
2021-02-23
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for minor updates to the RNS® Tablet. NeuroPace is requesting approval for addition of Mobile Device Management (MDM) capability on the tablet platform as well as changes to the login requirements for accessing the NeuroPace Programmer Application on the tablet.