Zephyr Endobronchial Valve (EBV) System
FDA premarket approval P180002/S014 · decided 2019-12-06
Approval details
- PMA number
- P180002
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Zephyr Endobronchial Valve (EBV) System
- Generic name
- Valve, pulmonary
- Applicant
- Pulmonx Corporation
- Date received
- 2019-11-08
- Decision date
- 2019-12-06
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Manufacturing change of adding the option of performing lot release testing of the Zephyr Endobronchial Delivery Catheter (EDC) before sterilization.
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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 |
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