FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Valve, Pulmonary
PMA: P180007
·
Decision Dec 3, 2018
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Valve, Pulmonary
- Trade Name
- Spiration® Valve System
- PMA Number
- P180007
- 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
- December 3, 2018
- Date Received
- February 5, 2018
- Expedited Review
- N
- Docket Number
- 18M-4665
Advisory Committee Statement
Approval of the Spiration® Valve System. The Spiration® Valves are one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have low 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 |