PMA P180002
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S020
- Product code
- NJK
- Decision date
- 2026-03-17
- Generic name
- Valve, pulmonary
- Approval order statement
- Removal of the ambient aeration step of the ethylene oxide (EO) sterilization process.
Current openFDA PMA Record#
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S030
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2026-03-17
- Decision code
- OK30
- Date received
- 2026-02-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of the ambient aeration step of the ethylene oxide (EO) sterilization process.