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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.
 
DeviceLungFX™ Device
Generic NameNormothermic preservation system for transplantation of initially unacceptable donor lungs
ApplicantLung Bioengineering, Inc.
Lb1 Bldg.
1015 Spring St.
Silver Spring, MD 20910
PMA NumberP240033
Supplement NumberS002
Date Received07/22/2026
Decision Date10/16/2026
Product Code PHO 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240033.
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