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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 NumberS051
Date Received02/24/2004
Decision Date04/29/2004
Product Code LYJ 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATIVE STERILIZATION PROCESS (HYDROGEN PEROXIDE GAS PLASMA USING THE STERRAD 200 GMP STERILIZER) FOR THE MODEL 302 LEAD AND MODEL 502 ACCESSORY PACK AND APPROVAL FOR A THREE YEAR SHELF LIFE FOR THE MODEL 302 LEAD AND MODEL 502 ACCESSORY PACK.
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