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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) Heart System
Generic NameOrgan care system (OCS) heart system
ApplicantTransMedics, Inc.
200 Minuteman Road, Suite 302
Andover, MA 01810
PMA NumberP180051
Date Received12/26/2018
Decision Date09/03/2021
Product Code QIK 
Docket Number 21M-0989
Notice Date 09/10/2021
Advisory Committee Cardiovascular
Clinical TrialsNCT02323321
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Organ Care System (OCS) Heart System. This device is indicated for the preservation of donor-after-brain-death (DBD) hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., > 4 hours of cross-clamp time).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001  S004 S002 S003 
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