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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOrgan Care System (OCS™) Liver
Generic NameNormothermic machine perfusion system for the preservation of donor livers prior to transplantation
ApplicantTransMedics, Inc.
200 Minuteman Rd.
Suite 302
Andover, MA 01810
PMA NumberP200031
Date Received06/30/2020
Decision Date09/28/2021
Product Code QQK 
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT02522871
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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:  S001 S002 S003 S004 S006 S007 S009 S010 S011 S012 S013 
S014 
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