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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 FOR EPILEPSY
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS222
Date Received01/15/2019
Decision Date02/14/2019
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
Approval Order Statement  
Approval for the following labeling updates:1) Model 1000 (SN < 100,000) High Impedance Warning - the addition of a warning to the VNS Therapy Physicians Manuals for both Epilepsy and Depression regarding the potential for erroneous high impedance warning messages that can be received in certain Model 1000 Generators (i.e. Serial Number (SN) < 100,000); and2) Model 1000 (SN < 100,000) Package Insert: the creation of a package insert, containing the same warning information described above, that will be placed within the sales packaging of every Model 1000 Generator (SN < 100,000).
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