PMA P180002S024
- Device
- modified 4.0-LP funnel component
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S024
- Product code
- NJK
- Decision date
- 2023-09-05
- Classification
- Anesthesiology
- Generic name
- Valve, pulmonary
- Approval order statement
- Approval for the proposed design changes to the funnel of the Endobronchial Loader System that is included with the Zephyr 4.0-LP Endobronchial valve model.
Current openFDA PMA Record#
- Device
- modified 4.0-LP funnel component
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S024
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2023-09-05
- Decision code
- APPR
- Date received
- 2023-06-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the proposed design changes to the funnel of the Endobronchial Loader System that is included with the Zephyr 4.0-LP Endobronchial valve model.