|
Device | Organ Care System (OCS™) Lung System |
Generic Name | Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation |
Applicant | TransMedics, Inc 200 Minuteman Road Suite 302 Andover, MA 01810 |
PMA Number | P160013 |
Supplement Number | S010 |
Date Received | 08/30/2022 |
Decision Date | 02/24/2023 |
Product Codes |
PHO QBA |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revised labeling to reflect the final results of INSPIRE, Lung EXPAND and Lung EXPAND II clinical trials. |