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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 DEMIPULSE/DEMIPULSE DUO GENERATORS
Classification Namestimulator, autonomic nerve, implanted for epilepsy
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS125
Date Received03/31/2011
Decision Date04/29/2011
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification of visual inspection acceptance criteria for three capacitors.
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