PMA P160013S007
- Device
- Organ Care System (OCS) Lung System
- Applicant
- TransMedics, Inc.
- PMA number
- P160013
- Supplement
- S007
- Product code
- QBA
- Decision date
- 2020-12-03
- Generic name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
- Approval order statement
- Approval for a software update (Software Version 3.1.3-C).
Current openFDA PMA Record#
- Device
- Organ Care System (OCS) Lung System
- Applicant
- TransMedics, Inc.
- PMA number
- P160013
- Supplement
- S007
- Product code
- QBA
- Generic name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
- Decision date
- 2020-12-03
- Decision code
- APPR
- Date received
- 2020-09-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software update (Software Version 3.1.3-C).