ESTEEM SYSTEM

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Premarket Approval P090018 S028

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

New supplier for the header component of the sound processor.

DeviceESTEEM SYSTEM
Classification NameImplant, Hearing, Active, Middle Ear, Totally Implanted
Generic NameImplant, Hearing, Active, Middle Ear, Totally Implanted
ApplicantENVOY MEDICAL CORPORATION
Date Received2014-12-31
Decision Date2015-01-30
PMAP090018
SupplementS028
Product CodeOAF
Advisory CommitteeEar Nose & Throat
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ENVOY MEDICAL CORPORATION 4875 White Bear Parkway white Bear Lake, MN 55110

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
20812282020225 P090018 000
00812282020368 P090018 000
00812282020320 P090018 000
00812282020313 P090018 000
00812282020276 P090018 000
00812282020252 P090018 000
00812282020207 P090018 000
00812282020191 P090018 000
00812282020184 P090018 000
00812282020177 P090018 000
00812282020160 P090018 000
00812282020146 P090018 000
00812282020139 P090018 000
00812282020122 P090018 000
00812282020078 P090018 000
00812282020269 P090018 000
00812282020610 P090018 000
00812282020573 P090018 000
00812282020559 P090018 000
00812282020542 P090018 000
00812282020535 P090018 000
00812282020528 P090018 000
00812282020474 P090018 000
00812282020467 P090018 000
00812282020450 P090018 000
00812282020443 P090018 000
00812282020436 P090018 000
00812282020016 P090018 001
00812282020047 P090018 001
00812282020351 P090018 005
00812282020337 P090018 005
00812282020344 P090018 005
00812282020481 P090018 009
00812282020399 P090018 014
00812282020290 P090018 014
00812282020306 P090018 014
00812282020382 P090018 014
00812282020405 P090018 014
00812282020412 P090018 014
00812282020030 P090018 016
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00812282020214 P090018 017
00812282020054 P090018 017
00812282020603 P090018 023
00812282020283 P090018 023
00812282020429 P090018 024
00812282020504 P090018 026
00812282020498 P090018 026

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