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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 PROSTHESIS (NCP) SYSTEM
Classification Namestimulator, autonomic nerve, implanted for epilepsy
Generic Namepulse generator
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS051
Date Received02/24/2004
Decision Date04/29/2004
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternative sterilization process (hydrogen peroxide gas plasma using the sterrad 200 gmp sterilizer) for the model 302 lead and model 502 accessory pack and approval for a three year shelf life for the model 302 lead and model 502 accessory pack.
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