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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 SYSTEM
Generic NameStimulator, autonomic nerve, implanted (depression)
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS148
Date Received05/24/2012
Decision Date07/23/2012
Product Codes LYJ MUZ 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE MODEL 250 PROGRAMMING SOFTWARE UPGRADE FROM VERSION 8.0 TO 8.1 AND THE ADDITION OF A NEW COMPACT FLASHCARD.
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