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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameVNS THERAPY SYSTEM
Classification Namestimulator, autonomic nerve, implanted for epilepsy
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS103
Date Received10/31/2008
Decision Date12/19/2008
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 addition of a software accessory/tool referred to as the ¿generator field upgrader¿ (gfu). The gfu is designed to be used to upgrade software in the demipulse, model 103 and demipulse duo, model 104 pulse generators to either enhance pre-existing features or to resolve software anomalies.
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