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BioWorld - Wednesday, December 6, 2023
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Home » Transmedics expands FDA PMA approval for heart transplant system
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Transmedics expands FDA PMA approval for heart transplant system

April 29, 2022
By Catherine Longworth
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The U.S. FDA has granted premarket approval for Transmedics Group Inc.’s OCS heart system for use with organs from donors after circulatory death (DCD). The approval expands on a prior FDA approval of the device for use with organs from donors after brain death in September 2021. Andover, Mass.-based Transmedics said its system can now be used for ex vivo reanimation, functional monitoring, and beating-heart preservation of donation-after-circulatory-death hearts.
BioWorld MedTech Regulatory U.S. FDA PMA

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