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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.
 
DeviceDEMIPULSE MODEL 103; ASPIREHC MODEL 105; ASPIRESR MODEL 106 GENERATOR.
Generic NameStimulator, autonomic nerve, implanted for epilepsy
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS200
Date Received05/23/2016
Decision Date11/23/2016
Product Codes LYJ MUZ 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Cyberonics Latam S.L.R., Edificio B49, 51 Ave 0, Zona Franca Coyol, Coyol - Alajuela, Costa Rica.
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