|
Device | Organ Care System™ (OCS™) Lung |
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 | S014 |
Date Received | 06/01/2023 |
Decision Date | 06/28/2023 |
Product Codes |
PHO QBA |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change the supplier for the vented bag component of the OCS Perfusion module. |