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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
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS014
Date Received12/21/1998
Decision Date01/20/1999
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 labeling changes being made to the model 100 ncp pulse generator physician's manual, the model 300 ncp bipolar lead physician's manual, and the patient's manual for the ncp system.
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