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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceLungFit PH
Generic NameNitric Oxide Generator and Delivery System
ApplicantBeyond Air, Inc.
825 East Gate Boulevard, Suite 320
Garden City, NY 11530
PMA NumberP200044
Date Received11/17/2020
Decision Date06/28/2022
Product Code QTB 
Docket Number 22M-2064
Notice Date 09/01/2022
Advisory Committee Anesthesiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for The LungFit® PH. The device is indicated to deliver nitric oxide (NO), a vasodilator, generated by the device into the inspiratory limb of the patient breathing circuit of a ventilator in a way that provides a constant concentration of NO, as set by the user, to the patient throughout the inspired breath. The LungFit® PH provides continuous integrated monitoring of inspired oxygen (O2), nitrogen dioxide (NO2) and NO, and a comprehensive alarm system. The LungFit® PH includes an integrated backup NO delivery system that is a completely independent backup NO generating system; it has its own NO generator and gas flow delivery system. The backup flow is delivered at 1 L/min at 220ppm NO to either a ventilator circuit or to a bagging system, depending upon the user selected setting. The NO generated by the LungFit® PH System is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S007 
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