Esteem® Totally Implantable Hearing System

FDA Premarket Approval P090018 S041

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

DeviceEsteem® Totally Implantable Hearing System
Generic NameImplant, Hearing, Active, Middle Ear, Totally Implanted
ApplicantENVOY MEDICAL CORPORATION4875 White Bear Parkwaywhite Bear Lake, MN 55110 PMA NumberP090018 Supplement NumberS041 Date Received03/23/2022 Decision Date08/24/2022 Product Code OAF  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
Date Received2022-03-23
Decision Date2022-08-24
PMAP090018
SupplementS041
Product CodeOAF 
Advisory CommitteeEar Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination ProductNo
Applicant AddressENVOY MEDICAL CORPORATION
4875 White Bear Parkway
white Bear Lake, MN 55110 PMA NumberP090018 Supplement NumberS041 Date Received03/23/2022 Decision Date08/24/2022 Product Code OAF  Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval Of Final Labeling Changes For The Post-approval Study (PAS) Referenced Above. The Updates To The Final PAS Labeling Have Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P090018.

Supplemental Filings

Supplement NumberDateSupplement Type
P090018Original Filing
S041 2022-03-23 Normal 180 Day Track No User Fee
S040
S039 2019-09-05 Normal 180 Day Track No User Fee
S038 2019-08-28 30-day Notice
S037 2018-05-02 Real-time Process
S036 2017-05-10 30-day Notice
S035 2017-03-17 30-day Notice
S034 2017-03-13 135 Review Track For 30-day Notice
S033 2016-10-28 Real-time Process
S032 2016-04-21 Normal 180 Day Track No User Fee
S031 2016-02-04 Normal 180 Day Track No User Fee
S030 2015-09-23 Normal 180 Day Track No User Fee
S029 2015-03-23 Real-time Process
S028 2014-12-31 30-day Notice
S027 2014-06-12 Real-time Process
S026 2014-05-23 Real-time Process
S025 2014-03-12 30-day Notice
S024 2013-08-08 Real-time Process
S023 2013-08-01 30-day Notice
S022
S021 2013-05-29 30-day Notice
S020 2013-05-01 Special (immediate Track)
S019 2013-04-19 Special (immediate Track)
S018 2012-08-29 30-day Notice
S017 2011-11-14 30-day Notice
S016 2011-11-02 Normal 180 Day Track
S015
S014 2011-10-24 Real-time Process
S013 2011-08-26 Real-time Process
S012 2011-08-16 30-day Notice
S011 2011-06-14 135 Review Track For 30-day Notice
S010 2011-05-20 Normal 180 Day Track No User Fee
S009 2011-05-10 Real-time Process
S008 2010-10-27 30-day Notice
S007 2010-08-18 30-day Notice
S006
S005 2010-08-09 30-day Notice
S004 2010-07-27 135 Review Track For 30-day Notice
S003 2010-06-17 Normal 180 Day Track No User Fee
S002 2010-06-17 Normal 180 Day Track No User Fee
S001 2010-04-07 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
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