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TransMedics Announces Temporary Postponement Of OCS Heart FDA Advisory Panel Committee Meeting


Benzinga | Sep 28, 2020 04:06PM EDT

TransMedics Announces Temporary Postponement Of OCS Heart FDA Advisory Panel Committee Meeting

ANDOVER, Mass., Sept. 28, 2020 (GLOBE NEWSWIRE) -- TransMedics Group, Inc. ("TransMedics") (NASDAQ:TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart and liver failure, today announced that the FDA has temporarily postponed the Advisory Committee meeting to review TransMedics' premarket approval application for its OCS Heart. The postponement of the meeting, which was-previously scheduled for October 7th, 2020 will allow the FDA time to review additional, already collected, short and longer-term data from the OCS Heart EXPAND trial and EXPAND Continued Access Protocol. The FDA's Office of Health Technology 2 (Cardiovascular Devices) has communicated to TransMedics that it will review the additional data expeditiously to allow rescheduling of the Advisory Panel meeting to occur in the near future.






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