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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 NumberS073
Date Received08/02/2019
Decision Date08/08/2019
Product Code PFN 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Modify the PXI Vader automated test equipment (ATE) software to improve yield of the components used to manufacture the RNS® Neurostimulator (model RNS-320) during the custom packaged integrated circuit (Cassandra) and printed circuit assembly (PCA) testing. In addition, this submission includes an update to PXI Vader ATE software for final electrical test to support future product changes currently under development.
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