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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 NumberS089
Date Received11/24/2021
Decision Date12/16/2021
Product Code PFN 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Add an existing NeuroPace supplier as an alternate supplier to manufacture the PEEK Connector Cover part of the Connector Cover Assemblies and Connector Cover Kits for the RNS Neurostimulators (Model RNS-320 and RNS-300M) and to manufacture this part by injection molding rather than by the current machining process.
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