Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
Applicant
NEUROPACE 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 Trials NCT00264810
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 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 S042 S043 S044 S045 
S046 S047 S048 S049 S050 S051 S052 S053 S054 
S056 S057 S058 S059 S060 S061 S063 S065 S066 
S067 S068 S069 S070 S071 S072 S073 S074 S075 
S076 S078 S079 S080 S081 S082 S083 S084 S085 
S086 
-
-