FDA.reportPublic FDA data

Esteem® IS-1 Lead End Cap

Primary DI
10812282020563
Brand
Esteem® IS-1 Lead End Cap
Company
Envoy Medical Corporation
Model
1400
Catalog number
701400-001
Device description
IS-1 Lead End Cap
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OAFImplant, Hearing, Active, Middle Ear, Totally Implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAFImplant, Hearing, Active, Middle Ear, Totally ImplantedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P090018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P090018000ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEMEnvoy Medical Corporation2010-03-17OAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812282020563PrimaryGS10
00812282020566Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081228202056310812282020563
00812282020566008122820205668122820205660812282020566

GMDN Terms#

Term, Definition table
TermDefinition
Fully-implantable middle ear implant systemAn implanted assembly of sterile devices intended to compensate for impaired hearing by transmitting vibrations to the middle ear. It is powered by a battery that is recharged inductively, via an external device. It consists of a capsule, containing the battery and processor unit, and an attached microphone and transducer that are fully implanted. The microphone receives sound waves that are converted into electrical signals which drive the transducer to vibrate the middle ear bones, stimulating the auditory pathway. A middle ear implant (MEI) is typically used to treat sensorineural hearing loss (SNHL) or hearing impairment due to middle and/or outer ear obstructive pathologies.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
651-361-8000info@envoymedical.com

Regulatory Flags#

DUNS number
939725313
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812282020009Esteem® Sensor7010907010-0012014-09-24
00812282020016Esteem® Driver7504907504-0012014-09-24
00812282020023Esteem® Driver7504907504-0032014-09-24
00812282020030Esteem® Driver7510907510-0012014-09-24
00812282020047Esteem® Sensor7004907004-0012014-09-24
00812282020054Esteem® Sensor7004907004-0032014-09-24
00812282020207Esteem® Sound Processor2001902001-0022014-09-24
00812282020214Esteem® Sound Processor2001902001-0032014-09-24
00812282020603Esteem MedCem1610901610-3012018-07-17
10812282020228Esteem® Bone Screws1790901790-0012014-09-24
10812282020235Esteem® Glasscock Stabilizers1730901730-0022014-09-24
10812282020242Esteem® Tapered Syringe Tips1725901725-0022014-09-24
10812282020518Esteem® Syringe1710701710-0022014-09-24
20812282020225Esteem® Bone Screws1790701790-0022014-09-24
00812282020078Esteem® Personal Programmer8001908001-1012014-09-24
00812282020122Esteem® Commander™6001906011-1022014-09-24
00812282020139Esteem® Intraoperative System Analyzer3001903200-0032014-09-24
00812282020146Esteem® Intraoperative System Analyzer3001903200-0052014-09-24
00812282020160Esteem® Intraoperative System Analyzer3001903001-0032014-09-24
00812282020177Esteem® Intraoperative System Analyzer3001913001-0012014-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812282020603Esteem MedCemEnvoy Medical CorporationOAF2018-07-17
00812282020610Esteem Intraoperative System AnalyzerEnvoy Medical CorporationOAF2018-03-28
00812282020498Esteem® Commander™Envoy Medical CorporationOAF2015-01-15
00812282020504Esteem® Commander™Envoy Medical CorporationOAF2015-01-15
10812282020228Esteem® Bone ScrewsEnvoy Medical CorporationOAF2014-09-24
10812282020235Esteem® Glasscock StabilizersEnvoy Medical CorporationOAF2014-09-24
10812282020242Esteem® Tapered Syringe TipsEnvoy Medical CorporationOAF2014-09-24
10812282020518Esteem® SyringeEnvoy Medical CorporationOAF2014-09-24
20812282020225Esteem® Bone ScrewsEnvoy Medical CorporationOAF2014-09-24
00812282020009Esteem® SensorEnvoy Medical CorporationOAF2014-09-24
00812282020016Esteem® DriverEnvoy Medical CorporationOAF2014-09-24
00812282020023Esteem® DriverEnvoy Medical CorporationOAF2014-09-24
00812282020030Esteem® DriverEnvoy Medical CorporationOAF2014-09-24
00812282020047Esteem® SensorEnvoy Medical CorporationOAF2014-09-24
00812282020054Esteem® SensorEnvoy Medical CorporationOAF2014-09-24
00812282020078Esteem® Personal ProgrammerEnvoy Medical CorporationOAF2014-09-24
00812282020122Esteem® Commander™Envoy Medical CorporationOAF2014-09-24
00812282020139Esteem® Intraoperative System AnalyzerEnvoy Medical CorporationOAF2014-09-24
00812282020146Esteem® Intraoperative System AnalyzerEnvoy Medical CorporationOAF2014-09-24
00812282020160Esteem® Intraoperative System AnalyzerEnvoy Medical CorporationOAF2014-09-24
00812282020177Esteem® Intraoperative System AnalyzerEnvoy Medical CorporationOAF2014-09-24
00812282020184Esteem® Intraoperative System AnalyzerEnvoy Medical CorporationOAF2014-09-24
00812282020191Esteem® Intraoperative System AnalyzerEnvoy Medical CorporationOAF2014-09-24
00812282020207Esteem® Sound ProcessorEnvoy Medical CorporationOAF2014-09-24
00812282020214Esteem® Sound ProcessorEnvoy Medical CorporationOAF2014-09-24
00812282020252Esteem® MedCem®Envoy Medical CorporationOAF2014-09-24
00812282020269Esteem® MedCem®Envoy Medical CorporationOAF2014-09-24
00812282020276Esteem® MedCem®Envoy Medical CorporationOAF2014-09-24
00812282020283Esteem® MedCem®Envoy Medical CorporationOAF2014-09-24
00812282020290Esteem® Transducer ReplicaEnvoy Medical CorporationOAF2014-09-24