Zephyr Endobronchial Valve (Zephyr Valve)
FDA premarket approval P180002/S019 · decided 2021-08-13
Approval details
- PMA number
- P180002
- Supplement
- S019
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Zephyr Endobronchial Valve (Zephyr Valve)
- Generic name
- Valve, pulmonary
- Applicant
- Pulmonx Corporation
- Date received
- 2021-07-16
- Decision date
- 2021-08-13
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for modifications to the protocol to include collection of perfusion data at baseline, extension of high-resolution computed tomography (HRCT) baseline data collection window from 3 months to 6 months prior to Informed Consent date, and collection of HRCT data at 12 months.
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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 |