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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLungFit PH
Generic NameNitric Oxide Generator and Delivery System
ApplicantBeyond Air, Inc.
825 E. Gate Blvd., Suite 320
Garden City, NY 11530
PMA NumberP200044
Supplement NumberS005
Date Received09/22/2023
Decision Date10/20/2023
Product Code QTB 
Advisory Committee Anesthesiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a new calibration guide labeling document to provide additional clarification of the calibration instructions provided in the Operator’s Manual
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