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.
| Device | XPS™ with Steen Solution™ Perfusate |
| Classification Name | Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs |
| Generic Name | Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs |
| Applicant | XVIVO Perfusion, Inc. |
| Date Received | 2018-05-10 |
| Decision Date | 2019-04-26 |
| PMA | P180014 |
| Supplement | S |
| Product Code | PHO |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | XVIVO Perfusion, Inc. 3666 S. Inca Street englewood, CO 80110 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P180014 | | Original Filing |
| S009 |
2022-02-08 |
Real-time Process |
| S008 |
2022-02-08 |
Real-time Process |
| S007 | | |
| S006 |
2021-10-04 |
Normal 180 Day Track No User Fee |
| S005 |
2020-09-23 |
Normal 180 Day Track No User Fee |
| S004 |
2020-01-27 |
Real-time Process |
| S003 |
2020-01-27 |
Real-time Process |
| S002 | | |
| S001 |
2019-05-28 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices