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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 NumberS215
Date Received12/04/2017
Decision Date02/14/2018
Product Codes LYJ MUZ 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for updates to the Model 3000 Programming Software (from v1.0 to v1.0.2 and then to v1.0.2.4) based on a field events which revealed that the M3000 v1.0 Software does not interrogate or program certain generator memory locations when used with Model 103, Model 104, Model 105 and Model 106 Generators.
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