|
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 | S006 |
Date Received | 10/04/2021 |
Decision Date | 11/03/2021 |
Product Code |
PHO |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval of the revised protocol for the post-approval study (PAS) protocol. |