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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 GENERATOR (DEMIPULSE) (ASPIREHC)
Classification Namestimulator, autonomic nerve, implanted for epilepsy
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS162
Date Received04/24/2013
Decision Date07/10/2013
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the transmit to receive refractory time which is a specification of the application specific integrated circuit (asic) used in model 103/104/105 vns generators and the implementation of a screening test to be performed at the vendor (on semiconductor).
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