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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; Model 3100 Programming Software; Model 2000 Programming Wand
Generic NameSTIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS241
Date Received04/03/2023
Decision Date09/15/2023
Product Codes LYJ MUZ 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the new Model 3100 v1.0 Programmer Software, updated M2000 v1.1.2.2 Programming Wand Firmware, and the new Digital Products Platform.
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