PMA P160013S008
- Device
- Organ Care System (OCS™) Lung System
- Applicant
- TransMedics, Inc.
- PMA number
- P160013
- Supplement
- S008
- Product code
- QBA
- Decision date
- 2021-08-02
- Generic name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
- Approval order statement
- Approval for an alternate check valve for the OCS Lung System.
Current openFDA PMA Record#
- Device
- Organ Care System (OCS™) Lung System
- Applicant
- TransMedics, Inc.
- PMA number
- P160013
- Supplement
- S008
- Product code
- QBA
- Generic name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
- Decision date
- 2021-08-02
- Decision code
- APPR
- Date received
- 2021-05-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an alternate check valve for the OCS Lung System.