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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 NumberS070
Date Received06/03/2019
Decision Date08/01/2019
Product Code PFN 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the following protocol changes and associated changes to data collection and informed consent forms:1) Increase the upper limit on the number of subjects that can be implanted per study site;2) Simplify the text to remove references to activities that are not study-specific (i.e. are standard in the management of the RNS System);3) Revise inclusion/exclusion criteria to only include study-specific criteria;4) Add the option of phone appointments for specific follow-up time points; and5) Minor clarifications and administrative changes. for the post-approval studies (PAS) protocol.
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