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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® SenTiva® Model 1000 Generator, VNS Therapy® AspireSR Model 106 Generator, VNS Therapy® Demipulse Model 103
Generic NameStimulator, autonomic nerve, implanted for epilepsy
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS246
Date Received12/30/2024
Decision Date03/27/2025
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 to reduce the size of the universal product packaging (i.e. sales package product box) used in all of the VNS Therapy IPGs, Leads and Accessory Pack
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