PMA P160013S005
- Device
- Organ Care System (OCS) Lung System
- Applicant
- TransMedics, Inc.
- PMA number
- P160013
- Supplement
- S005
- Product code
- QBA
- Decision date
- 2019-12-20
- Generic name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
- Approval order statement
- Approval for a change in the OCS Monitor Battery printed circuit board.
Current openFDA PMA Record#
- Device
- Organ Care System (OCS) Lung System
- Applicant
- TransMedics, Inc.
- PMA number
- P160013
- Supplement
- S005
- Product code
- QBA
- Generic name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
- Decision date
- 2019-12-20
- Decision code
- APPR
- Date received
- 2019-09-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in the OCS Monitor Battery printed circuit board.