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Device | XVIVO Perfusion System (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 |
Supplement Number | S008 |
Date Received | 02/08/2022 |
Decision Date | 05/09/2022 |
Product Code |
PHO |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a software upgrade in the XPS (software v5.3.0) to address minor bug fixes and to remove the software control of XPS’ auxiliary pumps. |