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) | Registration & Listing | Adverse Events | Recalls | PMA | 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.
 
Trade NameNEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Classification Namestimulator, autonomic nerve, implanted for epilepsy
Generic Namepulse generator
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS055
Date Received11/08/2004
Decision Date02/01/2005
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 250 programming software - version 7. 0 for use with model 100 versions b and c, model 101 versions 1 and 2, and models 102 and 102r pulse generators.
-
-