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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNEUROPACE RNS SYSTEM
Generic NameImplanted brain stimulator for epilepsy
ApplicantNEUROPACE INC
455 N. BERNARDO AVE
MOUNTAIN VIEW, CA 94043
PMA NumberP100026
Date Received07/02/2010
Decision Date11/14/2013
Product Code PFN 
Docket Number 12M-1488
Notice Date 11/25/2013
Advisory Committee Neurology
Clinical TrialsNCT00264810
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE RNS SYSTEM. THIS DEVICE IS INDICATED AS FOLLOWS: " ... AS AN ADJUNCTIVE THERAPY IN REDUCING THE FREQUENCY OF SEIZURES IN INDIVIDUALS 18 YEARS OF AGE OR OLDER WITH PARTIAL ONSET SEIZURES WHO HAVE UNDERGONE DIAGNOSTIC TESTING THAT LOCALIZEDNO MORE THAN 2 EPILEPTOGENIC FOCI, ARE REFRACTORY TO TWO OR MORE ANTIEPILEPTIC MEDICATIONS, AND CURRENTLY HAVE FREQUENT AND DISABLING SEIZURES (MOTOR PARTIAL SEIZURES, COMPLEX PARTIAL SEIZURESAND/ OR SECONDARILY GENERALIZED SEIZURES). THE RNS SYSTEM HAS DEMONSTRATED SAFETY AND EFFECTIVENESS IN PATIENTS WHO AVERAGE 3 OR MORE DISABLING SEIZURES PER MONTH OVER THE THREE MOST RECENT MONTHS (WITH NO MONTH WITH FEWER THAN TWO SEIZURES), AND HAS NOT BEEN EVALUATED IN PATIENTS WITH LESS FREQUENT SEIZURES."
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S087 S088 S089 S050 S080 S081 S082 S047 S048 S044 S045 S046 
S043 S042 S008 S009 S010 S011 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S030 
S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041  
S091 S092 S001 S002 S003 S004 S005 S006 S007 S086 S049 S057 
S058 S059 S084 S083 S067 S075 S076 S063 S053 S051 S052 S060 
S056 S054 S072 S065 S073 S074 S061 S068 S069 S070 S071 S078 
S079 S066 S090 S085 S093 S095 S096 S097 S098 S094 
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