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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 NumberS196
Date Received04/18/2016
Decision Date07/13/2016
Product Codes LYJ MUZ 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the following device changes: 1) The Model 106 Generator’s technical requirement for Heartbeat amplitude detection is being updated to include a minimum lower threshold (i.e. Minimum alower) for each of the generators five (5) gain settings (as well as adjustments to the maximum lower threshold (i.e. alower); 2) The Universal Test System is being updated of the Model 106 Generator so that the updated firmware can be loaded onto Model 106 generators; and 3) Universal Test System (UTS) Updates and Improvements.
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