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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 NumberS044
Date Received10/17/2016
Decision Date11/16/2016
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  
Move the location of the laser and resistance welding processes for neurostimulator and ferrule components to their new manufacturing facility in a NeuroPace’s approved sub-contractor, Cirtec Medical Systems (Cirtec), in Enfield, Connecticut.
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