Zephyr Endobronchial Valve System
FDA premarket approval P180002/S025 · decided 2024-03-22
Approval details
- PMA number
- P180002
- Supplement
- S025
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Zephyr Endobronchial Valve System
- Generic name
- Valve, pulmonary
- Applicant
- Pulmonx Corporation
- Date received
- 2023-12-21
- Decision date
- 2024-03-22
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval of the labeling supplement as required by the PASR letter issued following the PAS final report P180002/R020.
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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 |