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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 NumberS224
Date Received04/24/2019
Decision Date05/22/2019
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  
Add an alternate hydrogen peroxide (HP) sterilizer (STERIS DLTS-V-S7) to the manufacturing process for the sterilization of all sterile VNS Therapy products including Generators (M102, M102R, M103, M104, M106, M1000, M7103 and M8103), Leads (M302, M303, M304 and M7304), Tunneler (M402), and the Accessory Pack (M502).
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