Identity
- Trade Name
- Zephyr Endobronchial Valve System FDA PMA
- Generic Name
- Valve, pulmonary FDA PMA
Identifiers
- PMA Number
- P180002 FDA PMA
- FDA Product Code
- NJK FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Anesthesiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Zephyr Endobronchial Valve System is an implantable bronchial valve indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation. It is designed to reduce lung volume in targeted areas to improve breathing function.
The device is supplied sterile for single-use implantation via bronchoscopy. It is regulated as a Class III medical device under FDA PMA approval (P180002) and is intended for use in hospital or clinical settings by trained physicians.
Frequently asked questions
What is the Zephyr Endobronchial Valve System used for?
The Zephyr Endobronchial Valve System is indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation, as stated in the approval documentation.
Is the Zephyr Endobronchial Valve System reusable or single-use?
The device is supplied sterile for single-use implantation via bronchoscopy, meaning it is intended for one-time use only and should not be reprocessed or reused.
What regulatory authorization does the Zephyr Endobronchial Valve System have?
The Zephyr Endobronchial Valve System has received FDA Premarket Approval (PMA) under application number P180002, which was approved on June 29, 2018.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Zephyr (Betriebssystem) – Wikipedia, Zephyr Project - GitHub, Was ist Zephyr? Das Open-Source-RTOS erklärt, Zephyr (operating system) - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P180002 | Class III | Active |
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Manufacturer
- Manufacturer
- Pulmonx Corporation
Sources (1)
- FDA PMA P180002 24 fields · synced Sep 18, 2026