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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
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
Supplement NumberS002
Date Received08/14/2018
Decision Date05/31/2019
Product Code
QBA[ Registered Establishments with QBA ]
Docket Number 19M-2671
Notice Date 06/04/2019
Advisory Committee Gastroenterology/Urology
Clinical Trials NCT01963780
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Organ Care System (OCS™) Lung System. The TransMedics Organ Care System (OCS) Lung is a portable, normothermic organ perfusion, ventilation and monitoring medical device indicated for preservation of standard criteria donor lung pairs and for preservation of donor lung pairs initially deemed unacceptable for procurement and transplantation based on limitations of cold static preservation. The device allows for ex vivo assessment of donor lungs prior to transplantation.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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