|
Device | NeuroPace RNS System |
Generic Name | Implanted brain stimulator for epilepsy |
Applicant | NEUROPACE INC 455 N. BERNARDO AVE MOUNTAIN VIEW, CA 94043 |
PMA Number | P100026 |
Supplement Number | S090 |
Date Received | 04/29/2022 |
Decision Date | 07/28/2022 |
Product Code |
PFN |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |