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 record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNeuroPace RNS System
Generic NameImplanted brain stimulator for epilepsy
ApplicantNeuroPace, Inc.
455 N Bernardo Ave.
Mountain View, CA 94043
PMA NumberP100026
Supplement NumberS072
Date Received06/20/2019
Decision Date06/24/2019
Product Code PFN 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change the glass weave used to produce the inner core in the fabrication of the printed circuit board (PCB) of the RNS Neurostimulator (Model RNS-320).
-
-