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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 | S001 |
Date Received | 08/27/2014 |
Decision Date | 11/10/2014 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for software changes for the device (revision 3. 0). |