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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, VNS THERAPY PROGRAMMING SOFTWARE (V11.0.4)
Generic NameStimulator, autonomic nerve, implanted (depression)
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS183
Date Received07/29/2015
Decision Date10/28/2015
Product Codes LYJ MUZ 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE INTRODUCTION OF THE MOTION CL910 AND MINOR MODIFICATIONS AND ENHANCEMENTS TO THE VNS THERAPY PROGRAMMING SOFTWARE MODEL 250 VERSION 11.0.4.
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