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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.
 
DeviceVNS THERAPY SYSTEM
Generic NameSTIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS103
Date Received10/31/2008
Decision Date12/19/2008
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 ADDITION OF A SOFTWARE ACCESSORY/TOOL REFERRED TO AS THE ¿GENERATOR FIELD UPGRADER¿ (GFU). THE GFU IS DESIGNED TO BE USED TO UPGRADE SOFTWARE IN THE DEMIPULSE, MODEL 103 AND DEMIPULSE DUO, MODEL 104 PULSE GENERATORS TO EITHER ENHANCE PRE-EXISTING FEATURES OR TO RESOLVE SOFTWARE ANOMALIES.
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