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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name active implantable bone conduction hearing system
De Novo Number DEN170009
Device Name Bonebridge
Requester
MED-EL Elektromedizinische Geraete GmbH
fuerstenweg 77a
innsbruck,  AT 6020
Contact elizabeth gfoeller
Regulation Number874.3340
Classification Product Code
PFO  
Date Received02/13/2017
Decision Date 07/20/2018
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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