LungFit PH
FDA premarket approval P200044/S003 · decided 2023-09-10
Approval details
- PMA number
- P200044
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LungFit PH
- Generic name
- Nitric Oxide Generator and Delivery System
- Applicant
- Beyond Air, Inc.
- Date received
- 2023-05-01
- Decision date
- 2023-09-10
- Days to decision
- 132 days
- Decision code
- APPR
- Product code
- QTB
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Garden City, NY
- Statement
- Approval for minor software changes to add support for future language translations, enhance manfucaturability and serviceability, refine alarms, limit the range for date changes, and for preparation of future compatibility and enhancements.
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