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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.
 
Trade NameNEUROPACE RNS SYSTEM
Classification Nameimplanted brain stimulator for epilepsy
ApplicantNEUROPACE INC
PMA NumberP100026
Supplement NumberS020
Date Received06/18/2014
Decision Date09/02/2014
Product Code
PFN[ Registered Establishments with PFN ]
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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