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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
Applicant
LivaNova USA, Inc.
100 cyberonics blvd.
houston, TX 77058
PMA NumberP970003
Supplement NumberS226
Date Received06/10/2019
Decision Date09/05/2019
Product Codes MUZ  LYJ 
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for Symmetry Model 8103 Generator for Depression, updates to MRI Labeling so that the Model 103 and Model 8103 Generator reflect the same expanded MRI conditions specified for the Model 105, Model 106 and Model 1000 Generator; and Model 3000 v1.5 Programmer Updates.
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