TransMedics Earns Second PMA For OCS Lung System
FDA approved a PMA supplement to allow TransMedics' Organ Care System (OCS) to be used for the preservation and ex-vivo assessment of lungs that would not be acceptable for transplant if they had been preserved with a standard cold static system.
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The US FDA panel will look at a PMA for the TransMedics OCS Liver System, which helps keep donor livers stable and healthy as they await transplant.
The US agency’s circulatory system devices panel will take up the company’s heart transplant tool in an October virtual session.
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week’s approvals include the US FDA's approval of a panel-track supplement for TransMedics' OCS Lung system to preserve donor lungs that would not be salvageable using a traditional cold static system.