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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™) Lung
Generic NameNormothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
ApplicantTransMedics, Inc
200 Minuteman Road
Suite 302
Andover, MA 01810
PMA NumberP160013
Supplement NumberS011
Date Received01/27/2023
Decision Date02/23/2023
Product Codes PHO QBA 
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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