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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 Rd.
Suite 302
Andover, MA 01810
PMA NumberP160013
Supplement NumberS010
Date Received08/30/2022
Decision Date02/24/2023
Product Codes PHO QBA 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for revised labeling to reflect the final results of INSPIRE, Lung EXPAND and Lung EXPAND II clinical trials.
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