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| Device | TorEx Lung Perfusion System |
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| Generic Name | Normothermic preservation system for transplantation of initially unacceptable donor lungs |
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| Applicant | Traferox Technologies, Inc.
3505 Laird Rd.
Unit 16
Mississauga L5L 5Y7 |
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| PMA Number | P250025 |
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| Date Received | 07/07/2025 |
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| Decision Date | 07/15/2026 |
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| Product Code |
PHO |
| Docket Number | 26M-7880 |
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| Notice Date | 07/15/2026 |
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| Advisory Committee |
Gastroenterology/Urology |
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| Clinical Trials | NCT05656404
|
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| Expedited Review Granted? | No |
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| Combination Product | Yes |
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| Predetermined Change Control Plan Authorized | No |
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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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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