FDA.reportPublic FDA data

MAXUM

Primary DI
M737M61021
Brand
MAXUM
Company
Ototronix, LLC
Model
M6102
Device description
Packaged OptiMAX Software
Published
2014-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MPVImplant, Hearing, Active, Middle Ear, Partially Implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPVImplant, Hearing, Active, Middle Ear, Partially ImplantedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P010023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010023000SOUNDTEC DIRECT SYSTEMOtotronix, LLC2001-09-07MPV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M737M61021PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Partially-implantable middle ear implant systemA battery-powered assembly of devices intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, to the middle ear. It primarily consists of an external microphone and a vibrator implanted in the middle ear that is coupled with an ossicle (middle ear bone) or the oval window. The microphone receives sound waves and converts them into electrical signals (radio waves) which are sent to the vibrator for the transmission of vibrations to the middle ear bones to activate 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.

Regulatory Flags#

DUNS number
833067478
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M737M31101MAXUMM31102022-03-29
M737M31991MAXUMM31992022-03-29
M737M53031MAXUMM53032022-03-29
M7379860011PROCEM986-001986-0012020-12-02
M7379860021PROCEM986-002986-0022020-12-02
M7379860031PROCEM986-003986-0032020-12-02
M7379860041PROCEM986-004986-0042020-12-02
M737P97201PROCEMP97202020-12-02
M737P97301PROCEMP97302020-12-02
M737P97401PROCEMP97402020-12-02
M737G50001OtogramG50002016-09-13
M737G55001OtogramG55002016-09-13
M737M210L1MAXUMM210L2014-09-03
M737M210R1MAXUMM210R2014-09-03
M737M220L1MAXUMM220L2014-09-03
M737M220R1MAXUMM220R2014-09-03
M737M31001MAXUMM31002014-09-03
M737M410L1MAXUMM410L2014-09-03
M737M410R1MAXUMM410R2014-09-03
M737M420L1MAXUMM420L2014-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09008737525286SAMBA 2 Hi AP unit, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737525293SAMBA 2 Hi AP unit, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737525309SAMBA 2 Lo AP unit, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737525316SAMBA 2 Lo AP unit, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737525347SAMBA 2 Hi PoM, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737525354SAMBA 2 Hi PoM, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737525361SAMBA 2 Lo PoM, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737525378SAMBA 2 Lo PoM, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526139SAMBA 2 Hi User Kit, RightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526146SAMBA 2 Hi User Kit, LeftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526153SAMBA 2 Lo User Kit, RightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526160SAMBA 2 Lo User Kit, LeftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526399SAMBA 2 Hi AP unit, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526405SAMBA 2 Hi AP unit, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526412SAMBA 2 Lo AP unit, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526429SAMBA 2 Lo AP unit, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526450SAMBA 2 Hi PoM, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526467SAMBA 2 Hi PoM, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526474SAMBA 2 Lo PoM, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737526481SAMBA 2 Lo PoM, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-12-05
09008737532925SAMBA 2 GO w/o manualsMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2022-11-16
M737M31101MAXUMOtotronix, LLCMPV2022-03-29
M737M31991MAXUMOtotronix, LLCMPV2022-03-29
M737M53031MAXUMOtotronix, LLCMPV2022-03-29
09008737520472SAMBA 2 Remote (Android)Med-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2020-09-08
09008737525033SYMFIT 8.0 DownloadMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2020-09-08
09008737525071SAMBA 2 GOMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2020-09-08
09008737525811SYMFIT 8.0 DVDMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2020-09-08
09008737525859SYMFIT 8.0 USBMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2020-09-08
09008737526030SAMBA 2 Remote (iOS)Med-El Elektromedizinische Geräte Gesellschaft m.b.H.MPV2020-09-08