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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 SYSTEM
Classification Namestimulator, autonomic nerve, implanted for epilepsy
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS004
Date Received09/18/1997
Decision Date01/29/1998
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for ncp(r) model 100c pulse generator with modifications to the microcontroller and battery. The device, as modified, will be marketed under the trade name ncp(r) model 100c pulse generator ans is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with pertial onset seizures, which are refractory to anti-epileptic medications.
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