|
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 | S006 |
Date Received | 09/23/2019 |
Decision Date | 12/20/2019 |
Product Codes |
PHO 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 a change in the material of the Large Valve Ball of the OCS Perfusion Module. |