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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 System
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 NumberS009
Date Received02/07/2022
Decision Date05/06/2022
Product Codes PHO QBA 
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 the addition of the Lung Small Trachea Cannula Set to the currently available trachea cannulas for the OCS Lung System.
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