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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
Classification Namestimulator, autonomic nerve, implanted (depression)
Generic Namestimulator, autonomic nerve, implanted (depression)
Applicant
LivaNova USA, Inc.
100 cyberonics blvd.
houston, TX 77058
PMA NumberP970003
Supplement NumberS050
Date Received10/27/2003
Decision Date07/15/2005
Product Code
MUZ[ Registered Establishments with MUZ ]
Docket Number 05M-0283
Notice Date 07/18/2005
Advisory Committee Neurology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
APPROVAL FOR THE VNS THERAPY SYSTEM. THE DEVICE IS INDICATED FOR THE ADJUNCTIVE LONG-TERM TREATMENT OF CHRONIC OR RECURRENT DEPRESSION FOR PATIENTS 18 YEARS OF AGE OR OLDER WHO ARE EXPERIENCING A MAJOR DEPRESSIVE EPISODE AND HAVE NOT HAD AN ADEQUATE RESPONSE TO FOUR OR MORE ADEQUATE ANTIDEPRESSANT TREATMENTS.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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