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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.
 
DeviceNeuro Cochlear Implant System
Generic NameImplant, cochlear
ApplicantOticon Medical
2720 Chemin Saint Bernard
Vallauris 06220
PMA NumberP200021
Supplement NumberS002
Date Received08/06/2021
Decision Date11/08/2021
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the external Neuro 2 Sound Processor firmware and to the Genie Medical Cochlear Implant fitting software.
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