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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 NumberS207
Date Received11/17/2016
Decision Date06/23/2017
Product Codes LYJ MUZ 
Docket Number 17M-3951
Notice Date 07/24/2017
Advisory Committee Neurology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the VNS Therapy System. The device is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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