LungFit PH
FDA premarket approval P200044/S008 · decided 2025-04-04
Approval details
- PMA number
- P200044
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LungFit PH
- Generic name
- Nitric Oxide Generator and Delivery System
- Applicant
- Beyond Air, Inc.
- Date received
- 2024-05-15
- Decision date
- 2025-04-04
- Days to decision
- 324 days
- Decision code
- APPR
- Product code
- QTB
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Garden City, NY
- Statement
- Approval for revised labeling to identify additional compatible ventilators
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