PMA P160013S003
- Device
- Organ Care System (OCS™) Lung System
- Applicant
- TransMedics, Inc.
- PMA number
- P160013
- Supplement
- S003
- Product code
- QBA
- Decision date
- 2018-12-21
- Classification
- Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
- Generic name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
- Approval order statement
- Approval for component changes to the printed circuit board (PCB), SD (Secure Digital) memory card, and cable connectors in the OCS Lung System.
Current openFDA PMA Record#
- Device
- Organ Care System (OCS™) Lung System
- Applicant
- TransMedics, Inc.
- PMA number
- P160013
- Supplement
- S003
- Product code
- QBA
- Generic name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
- Decision date
- 2018-12-21
- Decision code
- APPR
- Date received
- 2018-09-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for component changes to the printed circuit board (PCB), SD (Secure Digital) memory card, and cable connectors in the OCS Lung System.