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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceOrgan Care System (OCS™) Liver
Generic Namenormothermic machine perfusion system for the preservation of donor livers prior to transplantation
Applicant
TransMedics, Inc.
200 minuteman road
suite 302
andover, MA 01810
PMA NumberP200031
Date Received06/30/2020
Decision Date09/28/2021
Product Code QQK 
Advisory Committee Gastroenterology/Urology
Clinical Trials NCT02522871
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for Organ Care System (OCS) Liver for the indication of: The TransMedics® Organ Care System (OCS) Liver is a portable extracorporeal liver perfusion and monitoring system indicated for preservation and monitoring of hemodynamics and metabolic function which allows for ex-vivo assessment of liver allografts from donors after brain death (DBD) or liver allografts from donors after circulatory death (DCD) <=55 years old and with <=30 mins of warm ischemic time, macrosteatosis <=15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  
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