Zephyr Valve Registry (ZEVR)
FDA premarket approval P180002/S009 · decided 2019-10-02
Approval details
- PMA number
- P180002
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Zephyr Valve Registry (ZEVR)
- Generic name
- Valve, pulmonary
- Applicant
- Pulmonx Corporation
- Date received
- 2019-08-05
- Decision date
- 2019-10-02
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for the enrollment of at least 20 patients with the new sized Zephyr valve (5.5 LP EBV).
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|---|---|---|
| Chartis Precision Catheter (K253096) | Pulmonx Corporation | 2026-02-13 |
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| Lung Image Analysis (K212494) | Pulmonx Corporation | 2021-09-02 |
| Pulmonx Chartis Tablet Console (K180011) | Pulmonx Corporation | 2018-07-13 |