PMA P160013S013
- Device
- Organ Care System (OCS™) Lung System
- Applicant
- TransMedics, Inc.
- PMA number
- P160013
- Supplement
- S013
- Product code
- QBA
- Decision date
- 2023-06-28
- Classification
- Gastroenterology, Urology
- Generic name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Organ Care System (OCS™) Lung System
- Applicant
- TransMedics, Inc.
- PMA number
- P160013
- Supplement
- S013
- Product code
- QBA
- Generic name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
- Decision date
- 2023-06-28
- Decision code
- APPR
- Date received
- 2023-05-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.