FDA.reportPublic FDA data

De Novo DEN170009

Device
Bonebridge
Contact
elizabeth gfoeller
De Novo number
DEN170009
Product code
PFO
Regulation
874.3340
Classification name
active implantable bone conduction hearing system
Decision
granted (DENG)
Decision date
2018-07-20
Date received
2017-02-13
Classification advisory
Ear Nose & Throat
Review advisory
Ear Nose & Throat
Type
Direct

Current FDA Classification#

Product code
PFO
Device name
Active Implantable Bone Conduction Hearing System
Medical specialty
Ear, Nose, Throat
Device class
2
Regulation
874.3340
Implant
Y
Life sustain/support
N