Active Implantable Bone Conduction Hearing System

MED-EL Elektromedizinische Geraete GmbH

The following data is part of a De Novo classification by Med-el Elektromedizinische Geraete Gmbh with the FDA for Bonebridge.

Pre-market Notification Details

DeNovo IDDEN170009
Device Name:Bonebridge
ClassificationActive Implantable Bone Conduction Hearing System
Applicant MED-EL Elektromedizinische Geraete GmbH fuerstenweg 77a Innsbruck,  AT 6020
ContactElizabeth Gfoeller
Product CodePFO  
CFR Regulation Number874.3340 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardEar Nose & Throat
Classification AdvisoryEar Nose & Throat
Date Received2017-02-13
Decision Date2018-07-20
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order


Device IdentifiersubmissionNumberSupplement
09008738521805 DEN170009 000
09008738515293 DEN170009 000

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