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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOrgan Care System (OCS™) Liver
Generic NameNormothermic machine perfusion system for the preservation of donor livers prior to transplantation
ApplicantTransMedics, Inc.
200 Minuteman Road
Suite 302
Andover, MA 01810
PMA NumberP200031
Supplement NumberS003
Date Received03/06/2023
Decision Date05/09/2023
Product Code QQK 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change to the wireless monitor of the OCS Lung System, including replacing the obsolete display panel with an updated panel, replacing the existing CCFL backlight driver with an LED backlight driver, updating the Wireless Monitor PCBA with minor component updates.
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