PMA P180002S017
- Device
- Zephyr Endobronchial Valve System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S017
- Product code
- NJK
- Decision date
- 2020-11-19
- Generic name
- Valve, pulmonary
- Approval order statement
- Manufacturing changes affecting inspection of the Zephyr Endobronchial Delivery Catheter and the Endobronchial Valve.
Current openFDA PMA Record#
- Device
- Zephyr Endobronchial Valve System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S017
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2020-11-19
- Decision code
- OK30
- Date received
- 2020-10-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing changes affecting inspection of the Zephyr Endobronchial Delivery Catheter and the Endobronchial Valve.