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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 Model 3100 Programmer, VNS Therapy Model 2000 Programming Wand
Generic NameStimulator, autonomic nerve, implanted for epilepsy
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS251
Date Received09/02/2025
Decision Date11/25/2025
Product Codes LYJ MUZ 
Advisory Committee Neurology
Supplement TypeReal-Time Process
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 a new version of the M3100 v2.0 Clinician Programmer update, including a new Pause Therapy function, new version of the M2000 v1.1.3.0 Wand, and updates to the Digital Product Platform
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