Neuro Cochlear Implant System

FDA Premarket Approval P200021 S004

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

Modifications to the acceptance criteria for the chemical composition of the feedthrough sandblasting material and to the leak test method for the magnet casing

DeviceNeuro Cochlear Implant System
Generic NameImplant, Cochlear
ApplicantOticon Medical
Date Received2021-08-11
Decision Date2021-09-10
PMAP200021
SupplementS004
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
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

Device IDPMASupp
03663227803884 P200021 000
03663227002355 P200021 000
03663227002140 P200021 000
03663227002126 P200021 000
03663227801811 P200021 000
03663227801804 P200021 000
03663227801781 P200021 000
03663227003949 P200021 000
03663227003840 P200021 000
03663227003864 P200021 000
03663227003956 P200021 000
03663227004007 P200021 000
03663227803877 P200021 000
03663227803068 P200021 000
03663227801798 P200021 000
03663227801774 P200021 000
03663227801750 P200021 000
03663227801743 P200021 000
03663227801736 P200021 000
03663227004014 P200021 000
03663227002003 P200021 000

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