• 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 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 NumberS013
Date Received02/21/2014
Decision Date03/21/2014
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 an alternate supplier for the cortical strip lead assembly.
-
-