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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 NumberS013
Date Received05/13/2022
Decision Date11/04/2022
Withdrawal Date04/09/2024
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for increased temperature control of the brazing process of the implant assembly and adjustments to the in-process control methods for detecting hermeticity of the implant, for the Neuro Zti implant, as per the approval letter.
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