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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVNS THERAPY SYSTEM, MODEL 302
Classification Namestimulator, autonomic nerve, implanted for epilepsy
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS058
Date Received07/20/2005
Decision Date09/29/2005
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the model 302 lead physician's manual clarifying information regarding handling to avoid damage to the lead and helical electrodes.
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