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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOrgan Care System (OCS™) Lung System
Classification Namenormothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Generic Namenormothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Applicant
TransMedics, Inc
200 minuteman road
suite 302
andover, MA 01810
PMA NumberP160013
Date Received04/28/2016
Decision Date03/22/2018
Product Code
QBA[ Registered Establishments with QBA ]
Docket Number 18M-1237
Notice Date 04/10/2018
Advisory Committee Gastroenterology/Urology
Clinical Trials NCT01630434
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the OCS Lung System, indicated for the preservation of standard criteria donor lungs in a near physiologic, ventilated, and perfused state for double lung transplantation.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 
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