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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 NumberS239
Date Received02/01/2023
Decision Date03/02/2023
Product Codes LYJ MUZ 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate 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 updates to the warning and precaution sections in the VNS Therapy Physicians Manuals for both Epilepsy and Depression regarding a clearer message directing the reader to view and reference the LivaNova magnetic resonance imaging (MRI) guidelines for any considerations for MRI scans in patients with the VNS Therapy System.
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