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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 NumberS035
Date Received08/27/2001
Decision Date09/04/2001
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the labeling to add a contraindication regarding the use of diathermy on patients implanted with the neurocybernetic prosthesis (ncp(r)) system.
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