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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 SenTiva Model 1000 Generator, VNS Therapy Model 2000 Programming Wand, VNS Therapy Model 3000 Programmer
Generic NameStimulator, autonomic nerve, implanted for epilepsy
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS218
Date Received04/30/2018
Decision Date07/27/2018
Product Codes MUZ LYJ 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for updates to the Model1000 SenTiva Generator, Model2000 Programming Wand, and Model3000 Programmer; the updates are referred to as Version 1.5. These changes spanned new outer packaging for leads, generators, and accessory packs, Model1000 Generator firmware corrections, Model1000 Heart Rate Sensing requirement updates, Model2000 Wand Firmware Corrections, Model2000 Wand Label Cover Addition, and Model3000 Programmer Software Enhancements and Corrections.
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