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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 NumberS245
Date Received10/15/2024
Decision Date11/14/2024
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  
VNS Therapy Physician’s Manuals (Epilepsy and Depression): Update to the Warnings, Device Diagnostics, and General Troubleshooting sections to add information related to a Potential Loss of Function due to a stuck-closed reed switch. Additional update to the technical language to refer to the magnetic sensor more generally instead of specifying a “reed switch” to allow other technologies to be used without requiring additional labeling updates.• VNS Therapy Patient Guides (Epilepsy and Depression): Updates to the General Warnings, “How the Magnet Works”, General Malfunction, and Frequently Asked Questions to add information related to device malfunctions, and specifically potentially malfunction of the sensor in the M1000 or M1000-D device. Additionally, updates to remove unnecessary technical information about the “reed switch” and instead only provide information about the functions of the magnet.
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