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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 NumberS135
Date Received09/01/2011
Decision Date10/31/2011
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 an upgrade to the communication flash loader (cfl) portion of the firmware of the demipulse implantable pulse generators, model 103 and model 104.
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