Neuro Cochlear Implant System

FDA Premarket Approval P200021 S007

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

Changes related to the shipment configuration of the sound processor and operating room kit.

DeviceNeuro Cochlear Implant System
Generic NameImplant, Cochlear
ApplicantOticon Medical
Date Received2021-09-27
Decision Date2021-10-26
PMAP200021
SupplementS007
Product CodeMCM 
Advisory CommitteeEar Nose & Throat
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Oticon Medical 2720 Chemin Saint Bernard vallauris 06220

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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