|
Trade Name | 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 |
3666 s inca street |
englewood, CO 80110 |
|
HDE Number | H120003 |
Supplement Number | S004 |
Date Received | 10/23/2014 |
Decision Date | 04/10/2015 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Reason | postapproval study protocol - osb |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval of the post-approval study protocol. |