• 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.
 
DeviceVNS THERAPY SYSTEM
Classification Namestimulator, autonomic nerve, implanted for epilepsy
Generic Namestimulator, autonomic nerve, implanted for epilepsy
Applicant
LivaNova USA, Inc.
100 cyberonics blvd.
houston, TX 77058
PMA NumberP970003
Supplement NumberS075
Date Received12/15/2006
Decision Date02/12/2007
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE POST-APPROVAL STUDY.
-
-