PMA P180002S025
- Device
- Zephyr Endobronchial Valve System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S025
- Product code
- NJK
- Decision date
- 2024-03-22
- Classification
- Anesthesiology
- Generic name
- Valve, pulmonary
- Approval order statement
- Approval of the labeling supplement as required by the PASR letter issued following the PAS final report P180002/R020.
Current openFDA PMA Record#
- Device
- Zephyr Endobronchial Valve System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S025
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2024-03-22
- Decision code
- APPR
- Date received
- 2023-12-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval of the labeling supplement as required by the PASR letter issued following the PAS final report P180002/R020.