PMA P180002S009
- Device
- Zephyr Valve Registry (ZEVR)
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S009
- Product code
- NJK
- Decision date
- 2019-10-02
- Classification
- Valve, Pulmonary
- Generic name
- Valve, pulmonary
- Approval order statement
- Approval for the enrollment of at least 20 patients with the new sized Zephyr valve (5.5 LP EBV).
Current openFDA PMA Record#
- Device
- Zephyr Valve Registry (ZEVR)
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S009
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2019-10-02
- Decision code
- APPR
- Date received
- 2019-08-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the enrollment of at least 20 patients with the new sized Zephyr valve (5.5 LP EBV).