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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
Classification Namestimulator, autonomic nerve, implanted for epilepsy
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS071
Date Received08/24/2006
Decision Date10/17/2006
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
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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