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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.
 
DeviceNCP Model 201 Programming Wand, VNS Therapy AspireHC Model 105 Generator, VNS Therapy AspireSR, Model 106 Generator
Generic NameSTIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS206
Date Received11/07/2016
Decision Date12/06/2016
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  
The following four (4) changes being made to the surface mounting technology (SMT) processes associated with the Model 201 Programming Wand and the Model 105/106 Generator: 1) Introduction of a New Heller Reflow Oven*; 2) New No Clean (NC) solder paste with Improved Solder Coalescence Properties*; 3) Removal of Silkscreen PCBA Labeling (Model 105/106 Only); and 4) Addition of a Block Skip Function to SMT Pick & Place Software (Model 105/106 Only).
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