PMA P200044S007
- Device
- LungFit PH
- Applicant
- Beyond Air, Inc.
- PMA number
- P200044
- Supplement
- S007
- Product code
- QTB
- Decision date
- 2024-03-22
- Classification
- Anesthesiology
- Generic name
- Nitric Oxide Generator and Delivery System
- Approval order statement
- approval for a labeling update to add an eLearning tool on Beyond Air’s website.
Current openFDA PMA Record#
- Device
- LungFit PH
- Applicant
- Beyond Air, Inc.
- PMA number
- P200044
- Supplement
- S007
- Product code
- QTB
- Generic name
- Nitric Oxide Generator and Delivery System
- Decision date
- 2024-03-22
- Decision code
- APPR
- Date received
- 2024-02-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for a labeling update to add an eLearning tool on Beyond Air’s website.