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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 (depression)
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS130
Date Received06/27/2011
Decision Date07/29/2011
Product Code
MUZ[ Registered Establishments with MUZ ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the serial adapter cable power connector.
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