PMA P200044S001
- Device
- LungFit® PH
- Applicant
- Beyond Air, Inc.
- PMA number
- P200044
- Supplement
- S001
- Product code
- QTB
- Decision date
- 2022-12-28
- Generic name
- Nitric Oxide Generator and Delivery System
- Approval order statement
- Approval for revised labeling to identify additional compatible ventilators
Current openFDA PMA Record#
- Device
- LungFit® PH
- Applicant
- Beyond Air, Inc.
- PMA number
- P200044
- Supplement
- S001
- Product code
- QTB
- Generic name
- Nitric Oxide Generator and Delivery System
- Decision date
- 2022-12-28
- Decision code
- APPR
- Date received
- 2022-09-30
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for revised labeling to identify additional compatible ventilators