PMA P180002S027
- Device
- Zephyr Endobronchial Valve System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S027
- Product code
- NJK
- Decision date
- 2024-05-13
- Classification
- Anesthesiology
- Generic name
- Valve, pulmonary
- Approval order statement
- Approval for the change of using a modified funnel component for the Endobronchial Loader System included with the Zephyr 5.5 Endobronchial Valve (EBV)
Current openFDA PMA Record#
- Device
- Zephyr Endobronchial Valve System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S027
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2024-05-13
- Decision code
- APPR
- Date received
- 2024-02-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the change of using a modified funnel component for the Endobronchial Loader System included with the Zephyr 5.5 Endobronchial Valve (EBV)