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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 (NCIS)
Generic NameImplant, cochlear
ApplicantOticon Medical
2720 Chemin Saint Bernard
06220 Vallauris 06220
PMA NumberP200021
Supplement NumberS012
Date Received04/29/2022
Decision Date05/27/2022
Withdrawal Date04/09/2024
Product Code MCM 
Advisory Committee Ear Nose & Throat
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 (e.g., additional minor changes to the protocol to align with US sites routine practice reported to Oticon Medical in the course of study site recruitment) of the protocol for the post-approval study (PAS) protocol.
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