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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 |
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HDE Number | H120003 |
Supplement Number | S005 |
Date Received | 04/10/2015 |
Decision Date | 11/16/2015 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Apapproval for labeling changes to the xps systems operator¿s manual (revision k). |