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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 NumberS040
Date Received04/19/2002
Decision Date06/20/2002
Product Code LYJ 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE EXISTING MODEL 101 (VERSION 2) IN-LINE NCP PULSE GENERATOR AND MODEL 302 (VERSION 1) IN-LINE NCP BIPOLAR LEAD, RESULTING IN THE NEW VNS THERAPY PULSE, MODEL 102 GENERATOR AND THE VNS THERAPY LEAD, MODEL 302 (VERSION 1.1). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VNS THERAPY SYSTEM.
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