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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 NumberS071
Date Received08/24/2006
Decision Date10/17/2006
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES TO THE LABELING HARMONIZATION AND MODULARIZATION FOR PHYSICIAN PULSE GENERATOR AND LEAD LABELING: 1) THE ADDITION OF A MANUAL ENTITLED, ?REVISION/REPLACEMENT/REMOVAL PROCEDURE MANUAL?. 2) THE INCORPORATION OF THE PHYSICIAN?S MANUAL FOR THE MODEL 303 LEAD INTO THE HARMONIZED LABELING WHICH INCLUDES THE ADDITION OF THE MODULAR PHYSICIAN?S MANUAL ENTITLED, ?TECHNICAL INFORMATION ? VNS THERAPY PERENNIA MODEL 303 LEAD?. 3) REVISIONS TO THE ?IMPLANTATION PROCEDURE? MODULE.
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