|
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 |
Date Received | 04/28/2016 |
Decision Date | 03/22/2018 |
Product Codes |
PHO QBA |
Docket Number | 18M-1237 |
Notice Date | 04/10/2018 |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT01630434
|
Expedited Review Granted? | Yes |
Combination Product | No |
Approval Order Statement Approval for the OCS Lung System, indicated for the preservation of standard criteria donor lungs in a near physiologic, ventilated, and perfused state for double lung transplantation. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S016 |