FDA.reportPublic FDA data

PMA P100026S090

Device
NeuroPace RNS System
Applicant
NeuroPace, Inc.
PMA number
P100026
Supplement
S090
Product code
PFN
Decision date
2022-07-28
Generic name
Implanted brain stimulator for epilepsy
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.

Current openFDA PMA Record#

Device
NeuroPace RNS System
Applicant
NeuroPace, Inc.
PMA number
P100026
Supplement
S090
Product code
PFN
Generic name
Implanted brain stimulator for epilepsy
Decision date
2022-07-28
Decision code
APPR
Date received
2022-04-29
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
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.