modified 4.0-LP funnel component
FDA premarket approval P180002/S024 · decided 2023-09-05
Approval details
- PMA number
- P180002
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- modified 4.0-LP funnel component
- Generic name
- Valve, pulmonary
- Applicant
- Pulmonx Corporation
- Date received
- 2023-06-07
- Decision date
- 2023-09-05
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for the proposed design changes to the funnel of the Endobronchial Loader System that is included with the Zephyr 4.0-LP Endobronchial valve model.
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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 |