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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.
 
DeviceCYBERONICS VNS THERAPY SYSTEM
Generic NameStimulator, autonomic nerve, implanted (depression)
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS181
Date Received06/22/2015
Decision Date07/31/2015
Product Codes LYJ MUZ 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
USE OF NEW PROCESSES FOR REPROCESSING TABLET COMPUTERS RETURNED FROM THE FIELD AND A PROCESS TO INSTALL PREVIOUSLY APPROVED SOFTWARE UPGRADES ON TABLET COMPUTERS THAT HAVE BEEN DISTRIBUTED TO THE FIELD FOR THE CYBERONICS® VNS THERAPY® SYSTEM TABLET COMPUTERS (MOTION MODEL CL900 OR CYBERONICS MODEL 700, MOTION MODEL CL910 OR CYBERONICS MODEL 720).
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