Zephyr Valve Reigstry (ZEVR)
FDA premarket approval P180002/S022 · decided 2023-03-25
Approval details
- PMA number
- P180002
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Zephyr Valve Reigstry (ZEVR)
- Generic name
- Valve, pulmonary
- Applicant
- Pulmonx Corporation
- Date received
- 2023-02-23
- Decision date
- 2023-03-25
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for modifications to the protocol including an increase in study sites from 10 to 15 and minor clarification changes.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Chartis Precision Catheter (K253096) | Pulmonx Corporation | 2026-02-13 |
| Chartis Precision Catheter (K222340) | Pulmonx Corporation | 2022-12-01 |
| Lung Image Analysis (K212494) | Pulmonx Corporation | 2021-09-02 |
| Pulmonx Chartis Tablet Console (K180011) | Pulmonx Corporation | 2018-07-13 |