De Novo DEN150029
- Device
- Permaseal
- Contact
- linda morgan
- De Novo number
- DEN150029
- Product code
- PNQ
- Regulation
- 870.4510
- Classification name
- apical closure device
- Decision
- granted (DENG)
- Decision date
- 2016-07-27
- Date received
- 2015-06-22
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification#
- Product code
- PNQ
- Device name
- Apical Closure Device
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.4510
- Implant
- Y
- Life sustain/support
- N