PMA P240033
- Device
- Centralized Lung Evaluation System (CLES)
- Applicant
- Lung Bioengineering, Inc.
- PMA number
- P240033
- Product code
- PHO
- Decision date
- 2026-06-22
- Classification
- Gastroenterology, Urology
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- 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.
Current openFDA PMA Record#
- Device
- Centralized Lung Evaluation System (CLES)
- Applicant
- Lung Bioengineering, Inc.
- PMA number
- P240033
- Product code
- PHO
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Decision date
- 2026-06-22
- Decision code
- APPR
- Date received
- 2024-09-30
- 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.