TorEx Lung Perfusion System; TorEx Lung Perfusate
Traferox Technologies, Inc. · Normothermic preservation system for transplantation of initially unacceptable donor lungs · Gastroenterology, Urology
Open FDA's page for this record- PMA number
- P250025
- Supplement number
- S002
- Applicant
- Traferox Technologies, Inc.
- Street 1
- 3505 Laird Rd.
- Street 2
- Unit 16
- City
- Mississauga
- Zip
- L5L 5Y7
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Trade name
- TorEx Lung Perfusion System; TorEx Lung Perfusate
- Product code
- PHO
- Advisory committee
- GU
- Advisory committee description
- Gastroenterology, Urology
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Expedited review flag
- N
- Date received
- 2026-08-07
- Decision date
- 2026-10-30
- Decision code
- APPR
- Ao 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 P250025.
- Harmonized identifiers (openFDA)
- Device name
- Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3012102437, 2518435, 3027669473, 3007710603, 1220477, 1720734, 3013113864, 3003766921, 3003708554, 1047843, 3009736925, 3028907862, 3003152463
- FEI number
- 3012102437, 2518435, 3027669473, 3007710603, 1220477, 1720734, 3013113864, 3003766921, 3003708554, 1047843, 3009736925, 3028907862, 3003152463