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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
DeviceNeuroPace RNS System
Generic NameImplanted brain stimulator for epilepsy
PMA NumberP100026
Supplement NumberS090
Date Received04/29/2022
Decision Date07/28/2022
Product Code PFN 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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.