Neuro Cochlear Implant System (NCIS)

FDA Premarket Approval P200021 S012

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.

Pre-market Approval Supplement Details

DeviceNeuro Cochlear Implant System (NCIS)
Generic NameImplant, Cochlear
ApplicantOticon Medical2720 Chemin Saint Bernardvallauris 06220 PMA NumberP200021 Supplement NumberS012 Date Received04/29/2022 Decision Date05/27/2022 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
Date Received2022-04-29
Decision Date2022-05-27
PMAP200021
SupplementS012
Product CodeMCM 
Advisory CommitteeEar Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressOticon Medical
2720 Chemin Saint Bernard
vallauris 06220 PMA NumberP200021 Supplement NumberS012 Date Received04/29/2022 Decision Date05/27/2022 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 Approval Order Statement  
The Center For Devices And Radiological Health (CDRH) Of The Food And Drug Administration (FDA) Has Completed Its Review Of Your Premarket Approval Application (PMA) Supplement, Which Requested 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) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P200021. Based Upon The Information Submitted, The PMA Supplement Is Approved.

Supplemental Filings

Supplement NumberDateSupplement Type
P200021Original Filing
S014 2022-05-18 30-day Notice
S013
S012 2022-04-29 Normal 180 Day Track No User Fee
S011 2022-02-23 30-day Notice
S010 2021-12-15 Normal 180 Day Track No User Fee
S009 2021-10-08 30-day Notice
S008
S007 2021-09-27 30-day Notice
S006 2021-09-27 30-day Notice
S005 2021-08-23 30-day Notice
S004 2021-08-11 30-day Notice
S003 2021-08-11 30-day Notice
S002
S001 2021-07-23 Normal 180 Day Track No User Fee

NIH GUDID Devices

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