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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 PROTHESIS (NCP) SYSTEM
Classification Namestimulator, autonomic nerve, implanted for epilepsy
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS047
Date Received06/20/2003
Decision Date08/14/2003
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the neurocybernetic prothesis (ncp) system model 102r generator, human factors improvements to the model 102 generator and labeling changes to the model 302 lead which are indicated for use as an adjunctive therapy in reducing the frequency of seizures that are refractory to antiepileptic medications.
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