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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.
 
DeviceVNS THERAPY GENERATOR (DEMIPULSE) (ASPIREHC)
Classification Namestimulator, autonomic nerve, implanted (depression)
Generic Namestimulator, autonomic nerve, implanted (depression)
Applicant
Cyberonics, Inc.
100 cyberonics blvd.
houston, TX 77058-2017
PMA NumberP970003
Supplement NumberS162
Date Received04/22/2013
Decision Date07/10/2013
Product Code
MUZ[ Registered Establishments with MUZ ]
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 timewhich 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 thevendor (on semiconductor).
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