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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNEUROCYBERNETIC PROTHESIS (NCP) SYSTEM
Generic NameSTIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS047
Date Received06/20/2003
Decision Date08/14/2003
Product Code LYJ 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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