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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 PROSTHESES(NCP) SYSTEM
Generic NameSTIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS039
Date Received04/17/2002
Decision Date06/18/2002
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 MODIFICATIONS TO THE EXISTING MODEL 402 TUNNELING TOOL (VERSION 1), RESULTING IN THE NEW VNS THERAPY TUNNELER, MODEL 402 (VERSION 2), AND MODIFICATIONS TO THE EXISTING MODEL 500 ACCESSORY PACK, RESULTING IN THE NEW VNS THERAPY ACCESSORY PACK, MODEL 502.
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