DevicePMAs@therightstef:P180014_S000 / 0-8 JSONTXT

Approval for the XPS with Steen Solution Perfusate. This device is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex vivo function of the lungs can be reassessed for transplantation.

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PMA_MER 1 (1)