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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 ASPIRESR GENERATOR; VNS THERAPY PROGRAMMING SOFTWARE
Generic NameStimulator, autonomic nerve, implanted (depression)
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS189
Date Received01/29/2016
Decision Date02/26/2016
Product Codes LYJ MUZ 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a labeling change to inform clinicians of modified stimulator programming parameters to enhance safety in the use of the device.
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