FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Valve, Pulmonary
PMA: P180002
·
Decision Jun 29, 2018
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Valve, Pulmonary
- Trade Name
- Zephyr Endobronchial Valve System
- PMA Number
- P180002
- Device Class
- FDA Class 3
- Product Code
- NJK
- Generic Name
- Valve, pulmonary
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 29, 2018
- Date Received
- January 2, 2018
- Expedited Review
- N
- Docket Number
- 18M-2571
Advisory Committee Statement
Approval of the Pulmonx Zephyr® Endobronchial Valve System. The device 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NJK | Valve, Pulmonary | FDA class 3 | Unknown |