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De Novo DEN150056
- Device
- Acclarent Aera Eustachian Tube Balloon Dilation System
- Contact
- james patrick garvey
- De Novo number
- DEN150056
- Product code
- PNZ
- Regulation
- 874.4180
- Classification name
- eustachian tube balloon dilation device
- Decision
- granted (DENG)
- Decision date
- 2016-09-16
- Date received
- 2015-12-07
- Classification advisory
- Ear Nose & Throat
- Review advisory
- Ear Nose & Throat
- Type
- Direct
Current FDA Classification#
- Product code
- PNZ
- Device name
- Eustachian Tube Balloon Dilation Device
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation
- 874.4180
- Implant
- N
- Life sustain/support
- N