- Device
- Organ Care System (OCS™) Lung System
- Applicant
- TransMedics, Inc.
- PMA number
- P160013
- Supplement
- S016
- Product code
- QBA
- Generic name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
- Decision date
- 2024-01-09
- Decision code
- APPR
- Date received
- 2023-09-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Recommend Approval of Manufacturing Site Change and EO sterilization.