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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVNS THERAPY GENERATOR (DEMIPULSE) (ASPIREHC)
Generic NameStimulator, autonomic nerve, implanted (depression)
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS162
Date Received04/22/2013
Decision Date07/10/2013
Product Codes LYJ MUZ 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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