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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.
 
DeviceNEUROCYBERNETIC PROSTHESIS SYSTEM
Generic NameSTIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS034
Date Received05/21/2001
Decision Date06/29/2001
Product Code LYJ 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MODEL 101 IN-LINE PULSE GENERATOR (VERSION 2.0), MODEL 302 IN-LINE BIPOLAR LEADS (VERSION 1.0), MODEL 402 IN-LINE TUNNELING TOOL (VERSION 1.0 AND LABELING CHANGES.
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