FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Nitric Oxide Generator And Delivery System
PMA: P200044
·
Supplement: S001
·
Decision Dec 28, 2022
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Nitric Oxide Generator And Delivery System
- Trade Name
- LungFit® PH
- PMA Number
- P200044
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- QTB
- Generic Name
- Nitric Oxide Generator and Delivery System
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 28, 2022
- Date Received
- September 30, 2022
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for revised labeling to identify additional compatible ventilators
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 |
|---|---|---|---|
| QTB | Nitric Oxide Generator And Delivery System | FDA class 3 | Unknown |