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Global Device Approvals Snapshot: 28 May-3 June 2019

Executive Summary

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.

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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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