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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 NumberS098
Date Received02/06/2008
Decision Date04/03/2008
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two changes to he pulse generator software to eliminate a rare timing condition that may cause the software watchdog to, at the end of a magnet-initiated burst, report an error even though no such error occurred.
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