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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 NameNEUROCYBERNETIC PROSTHESES(NCP) SYSTEM
Classification Namestimulator, autonomic nerve, implanted for epilepsy
Generic Namepulse generator
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS039
Date Received04/17/2002
Decision Date06/18/2002
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the existing model 402 tunneling tool (version 1), resulting in the new vns therapy tunneler, model 402 (version 2), and modifications to the existing model 500 accessory pack, resulting in the new vns therapy accessory pack, model 502.
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