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Trade Name | XPS with STEEN Solution PErfusate (HDE #H120003) |
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 | S009 |
Date Received | 11/13/2018 |
Decision Date | 12/12/2018 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Change in the synergy health/steris ast sterilization site for the xvivo pgm disposable sensors from denver, co to petaluma, california. |