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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
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 NumberS011
Date Received02/12/2014
Decision Date05/07/2014
Product Code
PFN[ Registered Establishments with PFN ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of ethernet connectivity to access the patient data management system database.
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