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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.
Classification Namestimulator, autonomic nerve, implanted for epilepsy
PMA NumberP970003
Supplement NumberS115
Date Received09/21/2010
Decision Date11/18/2010
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to battery longevity design requirements and related labeling of battery longevity tables for your model 102 and 102r pulse generators.