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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 NumberS079
Date Received03/17/2020
Decision Date03/20/2020
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 Telemetry Only System (TOS) and PXI Vader Temperature Test System Automatic Test Equipment (ATE) databases to improve yield of the components usedto manufacture the RNS® Neurostimulator (model RNS-320).
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