PMA P240033S002

Device: LungFX™ Device
Applicant: Lung Bioengineering, Inc.
PMA number: P240033
Supplement: S002
Product code: PHO
Decision date: 2026-10-16
Classification: Gastroenterology, Urology
Generic name: Normothermic preservation system for transplantation of initially unacceptable donor lungs
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.

Current openFDA PMA Record#

Device: LungFX™ Device
Applicant: Lung Bioengineering, Inc.
PMA number: P240033
Supplement: S002
Product code: PHO
Generic name: Normothermic preservation system for transplantation of initially unacceptable donor lungs
Decision date: 2026-10-16
Decision code: APPR
Date received: 2026-07-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
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.