Premarket Approval (PMA)

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 Name: VNS THERAPY SYSTEM
• Classification Name: stimulator, autonomic nerve, implanted for epilepsy
• Applicant: CYBERONICS, INC.
• PMA Number: P970003
• Supplement Number: S083
• Date Received: 05/24/2007
• Decision Date: 05/01/2008
• Product Code: LYJ [ Registered Establishments with LYJ ]
• Advisory Committee: Neurology
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval study.