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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 NumberS012
Date Received11/25/2025
Decision Date12/16/2025
Product Code QQK 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a change in the pressure test condition in the inline leak test performed during assembly.
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