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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 (NCP) SYSTEM
Generic NameSTIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS032
Date Received03/23/2001
Decision Date05/10/2001
Product Code LYJ 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A NEW STERILIZATION SITE LOCATED AT STERITEC, INC., ATHENS, TEXAS, AS WELL AS LABELING PROCESS AND PACKAGING CHANGES, AND A COMBINED MODEL PHYSICIAN'S MANUAL.
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