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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.
 
DeviceNeuroPac RNS System
Generic NameImplanted brain stimulator for epilepsy
ApplicantNEUROPACE INC
455 N. BERNARDO AVE
MOUNTAIN VIEW, CA 94043
PMA NumberP100026
Supplement NumberS074
Date Received08/15/2019
Decision Date08/26/2019
Product Code PFN 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Addition of an alternate laser welder, the IPG Laser Weld System, to perform laser welding on the RNS Neurostimulator during manufacturing operations at NeuroPace (455 N. Bernardo Ave. Mountain, California).
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