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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 NumberS249
Date Received08/11/2025
Decision Date08/12/2026
Product Codes LYJ MUZ 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for 1) changing the term “partial onset seizures” to “focal onset seizures” in the Indications for Use, 2) changing the term “sudden unexplained death” to “sudden unexpected death”, 3) removing the “Warning” label associated with SUDEP-related information and moving the SUDEP-related information from the Warnings section to the Clinical Studies section of the Physician’s Manual, 4) aligning the SUDEP-related information in the Patient Guide with the Physician’s Manual and removing the “Caution” label associated with SUDEP-related information.
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