- Device
- Organ Care System™ (OCS) Lung System
- Applicant
- TransMedics, Inc.
- PMA number
- P160013
- Supplement
- S009
- Product code
- QBA
- Generic name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
- Decision date
- 2022-05-06
- Decision code
- APPR
- Date received
- 2022-02-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of the Lung Small Trachea Cannula Set to the currently available trachea cannulas for the OCS Lung System.