FDA.reportPublic FDA data

ENVOY MEDICAL CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30040077823004007782ENVOY MEDICAL CORPORATION1N2026-01-014875 White Bear Pkwy White Bear Lake MN US 55110

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00812282020009Esteem® Sensor - Sensor Model 7010, IS-1 Connector6513618000info@envoymedical.com
00812282020016Esteem® Driver - Driver Model 7504, IS-1 Connector6513618000info@envoymedical.com
00812282020023Esteem® Driver - Driver Model 7504, IS-1 Connector6513618000info@envoymedical.com
00812282020030Esteem® Driver - Driver Model 7510, IS-1 Connector6513618000info@envoymedical.com
00812282020047Esteem® Sensor - Sensor Model 7004, IS-1 Connector6513618000info@envoymedical.com
00812282020054Esteem® Sensor - Sensor Model 7004, IS-1 Connector6513618000info@envoymedical.com
00812282020207Esteem® Sound Processor - Sound Processor Model 2001, IS-1 Connector Ports6513618000info@envoymedical.com
00812282020214Esteem® Sound Processor - Sound Processor Model 2001, IS-1 Connector Ports6513618000info@envoymedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
254551150320875P090018ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEMOAF2010-03-17
254551545332852K080032ENVOYCEM, MODEL 1640NEA2008-02-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OAF12010-03-17
NEA12008-02-28

PMA#

Esteem® Totally Implantable Hearing System

2022-08-24

ENVOY 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 U...

Esteem

2020-02-24

ENVOY MEDICAL CORPORATION

Esteem

2017-06-09

ENVOY MEDICAL CORPORATION

Esteem

2017-05-24

ENVOY MEDICAL CORPORATION

ESTEEM

2017-01-26

ENVOY MEDICAL CORPORATION

ESTEEM

2016-12-12

ENVOY MEDICAL CORPORATION

ESTEEM

2016-08-01

ENVOY MEDICAL CORPORATION

ESTEEM

2016-03-18

ENVOY MEDICAL CORPORATION

ESTEEM

2015-06-19

ENVOY MEDICAL CORPORATION

ESTEEM

2014-09-10

ENVOY MEDICAL CORPORATION

ESTEEM

2014-08-21

ENVOY MEDICAL CORPORATION

ESTEEM

2013-11-04

ENVOY MEDICAL CORPORATION

ESTEEM

2013-08-27

ENVOY MEDICAL CORPORATION

ESTEEM

2013-06-25

ENVOY MEDICAL CORPORATION

ESTEEM

2013-03-26

ENVOY MEDICAL CORPORATION

ESTEEM

2012-11-13

ENVOY MEDICAL CORPORATION

ESTEEM

2012-09-28

ENVOY MEDICAL CORPORATION

ESTEEM

2012-06-22

ENVOY MEDICAL CORPORATION

ESTEEM

2011-12-14

ENVOY MEDICAL CORPORATION

ESTEEM

2011-10-28

ENVOY MEDICAL CORPORATION

ESTEEM

2011-09-23

ENVOY MEDICAL CORPORATION

ESTEEM

2011-09-21

ENVOY MEDICAL CORPORATION

ESTEEM

2011-07-07

ENVOY MEDICAL CORPORATION

ESTEEM

2011-05-06

ENVOY MEDICAL CORPORATION

ESTEEM

2010-12-14

ENVOY MEDICAL CORPORATION

ESTEEM

2010-11-23

ENVOY MEDICAL CORPORATION

ESTEEM

2010-09-21

ENVOY MEDICAL CORPORATION

ESTEEM

2010-09-08

ENVOY MEDICAL CORPORATION

ESTEEM

2010-08-16

ENVOY MEDICAL CORPORATION

ESTEEM

2010-08-16

ENVOY MEDICAL CORPORATION

PMN#

GUDID#

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