PMA P180002S031
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S031
- Product code
- NJK
- Decision date
- 2026-06-17
- Classification
- Anesthesiology
- Generic name
- Valve, pulmonary
- Approval order statement
- approval for the qualification of Confluent Medical (Fremont, CA) as a second source supplier for the nitinol retainer component of the Zephyr 5.5-LP EBV
Current openFDA PMA Record#
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S031
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2026-06-17
- Decision code
- OK30
- Date received
- 2026-05-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for the qualification of Confluent Medical (Fremont, CA) as a second source supplier for the nitinol retainer component of the Zephyr 5.5-LP EBV