|
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 | S003 |
Date Received | 09/27/2018 |
Decision Date | 12/21/2018 |
Product Code |
QBA |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |