ADVANCED BIONICS

FDA Filings

This page includes the latest FDA filings for ADVANCED BIONICS. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate

Latest Premarket Applications

PMAManufacturerDevice NameDate
ADVANCED BIONICS
HiResolution Bionic Ear System2020-01-17
ADVANCED BIONICS
HiResolution Bionic Ear System2019-12-17
ADVANCED BIONICS
HiResolution Bionic Ear System2019-10-25
ADVANCED BIONICS
HiResolution Bionic Ear System2019-08-27
ADVANCED BIONICS
HiResolution Bionic Ear System2019-08-23
ADVANCED BIONICS
HiResolution Bionic Ear System2019-07-18
ADVANCED BIONICS
HiResolution Bionic Ear System2019-07-03
ADVANCED BIONICS
HiResolution Bionic Ear System2019-03-22
ADVANCED BIONICS
Chorus Sound Processor and SoundWave Professional Suite 3.2/HiResolution Bionic Ear System2019-03-12
ADVANCED BIONICS
HiResolution Bionic Ear System2019-03-08
ADVANCED BIONICS
HiResolution Bionic Ear System2019-03-08
ADVANCED BIONICS
HiResolution Bionic Ear System2019-01-11
ADVANCED BIONICS
HiResolution Bionic Ear System2019-01-09
ADVANCED BIONICS
HiRes Ultra 3D Cochlear Implant2018-08-28
ADVANCED BIONICS
HiResolution Bionic Ear System2018-08-13
ADVANCED BIONICS
HiResolution Bionic Ear System2018-03-14
ADVANCED BIONICS
HiResolution Bionic Ear System2017-11-21
ADVANCED BIONICS
HiResolution Bionic Ear System2017-11-14
ADVANCED BIONICS
HiFocus SlimJ Electrode2017-11-14
ADVANCED BIONICS
HiResolution Bionic Ear System - Universal Headpiece (UHP) 2.02017-10-26
ADVANCED BIONICS
HiResolution Bionic Ear System2017-10-25
ADVANCED BIONICS
HiResolution Bionic Ear System2017-10-05
ADVANCED BIONICS
HiRESOLUTION BIONIC EAR SYSTEM2017-05-17
ADVANCED BIONICS
HiResolution Bionic Ear System2016-11-29
ADVANCED BIONICS
HIRESOLUTION BIONIC EAR SYSTEM, HIRES ULTRA COCHLEAR IMPLANT WITH THE HIFOCUS MID-SCALA ELECTRODE2016-07-15
ADVANCED BIONICS
HIRESOLUTION BIONIC EAR SYSTEM2015-11-24
ADVANCED BIONICS
HIRESOLUTION BIONIC EAR SYSTEM2015-09-18
ADVANCED BIONICS
HIRESOLUTION BIONIC EAR SYSTEM2015-09-02
ADVANCED BIONICS
HIRESOLUTION BIONIC EAR SYSTEM2015-08-14
ADVANCED BIONICS
HIRESOLUTION BIONIC EAR SYSTEM2015-05-19

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Auria™ PowerCel™ Charger
Advanced Bionics AG2020-02-06
1.3 Battery Charger
Advanced Bionics AG2020-02-06
Chorus Battery Charger
Advanced Bionics AG2020-02-06
Naida CI PowerCel™ Charger
Advanced Bionics AG2020-02-06
Naida CI PowerCel™ Charger
Advanced Bionics AG2020-02-06
HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode
Advanced Bionics AG2020-01-29
HiRes™ Ultra 3D CI HiFocus™ MS Electrode
Advanced Bionics AG2020-01-29
HiRes™ Ultra CI HiFocus™ SlimJ Electrode
Advanced Bionics AG2020-01-29
HiRes™ Ultra CI HiFocus™ MS Electrode
Advanced Bionics AG2020-01-29
AIM™ Rechargeable Battery
Advanced Bionics AG2019-06-27
AIM™ System
Advanced Bionics AG2019-06-19
AIM™ Insert Earphone
Advanced Bionics AG2019-06-07
AIM™ Rechargeable Battery
Advanced Bionics AG2019-06-07
AIM™ System
Advanced Bionics AG2019-06-07
AIM™ Programming Cable
Advanced Bionics AG2019-06-07
AIM™ Sterile Inserts
Advanced Bionics AG2019-06-07
SoundWave™ Professional Suite Software
Advanced Bionics AG2019-04-24
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29
Neptune™ Cable for UHP
Advanced Bionics AG2019-03-29

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