LungFit PH
FDA premarket approval P200044/S002 · decided 2023-04-21
Approval details
- PMA number
- P200044
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- 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
- 2023-03-24
- Decision date
- 2023-04-21
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- QTB
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Garden City, NY
- Statement
- Approval for an update to Pre-Use Guide (20092-01) to include a figure for bagging system connections which is already included in the Operators Manual and included in training.
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