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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 NumberS002
Date Received01/27/2023
Decision Date02/23/2023
Product Code QQK 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Expand the clean room area at the existing manufacturing facility.
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