- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S015
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2020-10-06
- Decision code
- APPR
- Date received
- 2019-12-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing change with the existing approved supplier Confluent Medical (Fremont, CA) for the nitinol retainer component of the Zephyr 4.0 EBV.