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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 NumberS002
Date Received03/24/2023
Decision Date04/21/2023
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 an update to Pre-Use Guide (20092-01) to include a figure for bagging system connections which is already included in the Operator’s Manual and included in training.
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