De Novo DEN150055
- Device
- AeroForm Tissue Expander System
- Contact
- robin` bush
- De Novo number
- DEN150055
- Product code
- PQN
- Regulation
- 878.3510
- Classification name
- carbon dioxide gas controlled tissue expander
- Decision
- granted (DENG)
- Decision date
- 2016-12-21
- Date received
- 2015-12-07
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- PQN
- Device name
- Carbon Dioxide Gas Controlled Tissue Expander
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.3510
- Implant
- Y
- Life sustain/support
- N