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| Device | Centralized Lung Evaluation System (CLES) |
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| Generic Name | Normothermic preservation system for transplantation of initially unacceptable donor lungs |
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| Applicant | Lung Bioengineering, Inc.
Lb1 Bldg.
1015 Spring St.
Silver Spring, MD 20910 |
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| PMA Number | P240033 |
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| Date Received | 09/30/2024 |
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| Decision Date | 06/22/2026 |
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| Product Code |
PHO |
| Advisory Committee |
Gastroenterology/Urology |
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| Clinical Trials | NCT03641677
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
This device (“LungFX”) is indicated for centralized, ex vivo (outside the body) evaluation of deceased-donor lungs (single and double) that cannot be placed for transplantation by an Organ Procurement Organization (OPO) with any of the matched candidates if using direct-to-recipient procurement and preservation procedures. LungFX provides normothermic perfusion and ventilation of procured donor lungs initially stored with cold static preservation solution.LungFX is intended to allow for re-assessment, in a controlled environment, of procured donor lungs’ suitability for transplantation into male and female patients aged 18 years or older with end-stage lung disease awaiting first time (double or single) lung transplantation. Lungs accepted for transplantation after LungFX require a second period of storage with cold static preservation solution, and cumulative preservation time of transplanted lungs is not intended to exceed 20 hours. |
| Post-Approval Study | Show Report Schedule and Study Progress |
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