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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
Classification Nameimplanted brain stimulator for epilepsy
Generic Nameimplanted brain stimulator for epilepsy
Applicant
NEUROPACE INC
455 n. bernardo ave
mountain view, CA 94043
PMA NumberP100026
Supplement NumberS010
Date Received01/28/2014
Decision Date02/25/2014
Product Code
PFN[ Registered Establishments with PFN ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ADD A SECOND SUPPLIER FOR THE PRINTED CIRCUIT ASSEMBLY.
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