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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 Rd.
Suite 302
Andover, MA 01810
PMA NumberP200031
Supplement NumberS007
Date Received07/18/2024
Decision Date01/13/2025
Product Code QQK 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the implementation of an alternative oxygenator, identified as the Maquet Quadrox-i, for the Organ Care System Liver
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