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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 NumberS003
Date Received09/27/2018
Decision Date12/21/2018
Product Code QBA 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for component changes to the printed circuit board (PCB), SD (Secure Digital) memory card, and cable connectors in the OCS Lung System.
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