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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
06220 Vallauris 06220
PMA NumberP200021
Supplement NumberS010
Date Received12/15/2021
Decision Date01/14/2022
Withdrawal Date04/09/2024
Product Code MCM 
Advisory Committee Ear Nose & Throat
Clinical TrialsNCT05154188
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the changes to approved protocol and enromment timeline for the post-approval study (PAS) protocol.
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