PMA P250025
- Device
- TorEx Lung Perfusion System
- Applicant
- Traferox Technologies, Inc.
- PMA number
- P250025
- Product code
- PHO
- Decision date
- 2026-07-15
- Classification
- Gastroenterology, Urology
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Approval order statement
- The TorEx Lung Perfusion System is indicated for use in continuous normothermic machine perfusion of donor lungs, initially deemed unsuitable for transplantation, during which time the ex vivo function of the lungs can be reassessed for transplantation in adults. The TorEx Lung Perfusion System includes a mobile cart with embedded software, single-use sterile Organ Chamber and Cannulae set and is used with TorEx Lung Perfusate solution to perform ex vivo lung perfusion for up to 6 hours.Note: The TorEx System is used to evaluate the quality of donated lungs, but the final determination of the suitability of the lungs for transplant remains with the transplanting surgeon.
Current openFDA PMA Record#
- Device
- TorEx Lung Perfusion System
- Applicant
- Traferox Technologies, Inc.
- PMA number
- P250025
- Product code
- PHO
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Decision date
- 2026-07-15
- Decision code
- APPR
- Date received
- 2025-07-07
- Approval order statement
- The TorEx Lung Perfusion System is indicated for use in continuous normothermic machine perfusion of donor lungs, initially deemed unsuitable for transplantation, during which time the ex vivo function of the lungs can be reassessed for transplantation in adults. The TorEx Lung Perfusion System includes a mobile cart with embedded software, single-use sterile Organ Chamber and Cannulae set and is used with TorEx Lung Perfusate solution to perform ex vivo lung perfusion for up to 6 hours.Note: The TorEx System is used to evaluate the quality of donated lungs, but the final determination of the suitability of the lungs for transplant remains with the transplanting surgeon.