PMA P180002S010
- Device
- Zephyr 5.5 EBV Circle Flange Valve
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S010
- Product code
- NJK
- Decision date
- 2019-11-13
- Classification
- Valve, Pulmonary
- Generic name
- Valve, pulmonary
- Approval order statement
- Approval for the Zephyr 5.5 EBV Circle Flange Valve.
Current openFDA PMA Record#
- Device
- Zephyr 5.5 EBV Circle Flange Valve
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S010
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2019-11-13
- Decision code
- APPR
- Date received
- 2019-08-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Zephyr 5.5 EBV Circle Flange Valve.