FDA.reportPublic FDA data

PMA P100026S082

Device
NeuroPace RNS System
Applicant
NeuroPace, Inc.
Product code
PFN
Decision date
2020-08-04
Generic name
Implanted brain stimulator for epilepsy
Approval order statement
Approval for a minor update to the RNS Tablet (programmer) software and related update to the Patient Data Management System (PDMS) software, and a minor product configuration change to remove the infrequently used dial-up accessories from the Remote Monitor Kit and supply them in a separate new kit (model 5104).

Current openFDA PMA Record#

Device
NeuroPace RNS System
Applicant
NeuroPace, Inc.
PMA number
P100026
Supplement
S082
Product code
PFN
Generic name
Implanted brain stimulator for epilepsy
Decision date
2020-08-04
Decision code
APPR
Date received
2020-05-11
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a minor update to the RNS Tablet (programmer) software and related update to the Patient Data Management System (PDMS) software, and a minor product configuration change to remove the infrequently used dial-up accessories from the Remote Monitor Kit and supply them in a separate new kit (model 5104).