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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
ApplicantNeuroPace, Inc.
455 N Bernardo Ave.
Mountain View, CA 94043
PMA NumberP100026
Supplement NumberS082
Date Received05/11/2020
Decision Date08/04/2020
Product Code PFN 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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).
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