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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 NumberS214
Date Received11/20/2017
Decision Date12/27/2017
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  
Change to the Leads Manufacturing Process to add the following two (2) processes on all commercially available Lead Models (302/303/304):1) Additional use of the currently approved primer; proposed application to the Suture and along the exposed edge of the Electrode; and2) Implementation of a Protection Aid to encapsulate the Lead Helicals, protecting them from Ribbon Damage during further processing steps. This will be removed at the end of the Lead Final assembly.
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