Neuro Cochlear Implant System

FDA Premarket Approval P200021 S014

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
Generic NameImplant, Cochlear
ApplicantOticon Medical2720 Chemin Saint Bernardvallauris 06220 PMA NumberP200021 Supplement NumberS014 Date Received05/18/2022 Decision Date06/17/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-18
Decision Date2022-06-17
PMAP200021
SupplementS014
Product CodeMCM 
Advisory CommitteeEar Nose & Throat
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressOticon Medical
2720 Chemin Saint Bernard
vallauris 06220 PMA NumberP200021 Supplement NumberS014 Date Received05/18/2022 Decision Date06/17/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
(1) Improved Equipment And Manufacturing Workflow At The Electronic Assembly Supplier; And (2) Modification To The Tooling Used For Feedthrough Leak Testing

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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