|
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 | S001 |
Date Received | 04/06/2018 |
Decision Date | 06/14/2018 |
Product Code |
QBA |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for protocol for post-approval study (PAS) protocol. |