|
Device | XPS™ with Steen Solution™ Perfusate |
Generic Name | Normothermic preservation system for transplantation of initially unacceptable donor lungs |
Applicant | XVIVO Perfusion, Inc. 3666 S. Inca Street Englewood, CO 80110 |
PMA Number | P180014 |
Date Received | 05/10/2018 |
Decision Date | 04/26/2019 |
Product Code |
PHO |
Docket Number | 19M-2052 |
Notice Date | 05/03/2019 |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT01365429
|
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the XPS™ with Steen Solution™ Perfusate. This device is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex vivo function of the lungs can be reassessed for 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 S003 S004 S005 S006 S007 S008 S009 S010 S011 |