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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.
 
DeviceOCS Heart System
Generic NameOrgan care system (OCS) heart system
ApplicantTransMedics, Inc.
200 Minuteman Rd., Suite 302
Andover, MA 01810
PMA NumberP180051
Supplement NumberS001
Date Received11/08/2021
Decision Date04/27/2022
Product Code QIK 
Docket Number 22M-0715
Notice Date 05/03/2022
Advisory Committee Cardiovascular
Clinical TrialsNCT03831048
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Organ Care System (OCS) Heart System for expanding the indication to include donation-after-circulatory-death (DCD) donor hearts. The device is indicated for the preservation of donation-after-brain-death (DBD) hearts initially 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). The OCS Heart System is also indicated for the ex vivo reanimation, functional monitoring, and beating-heart preservation of DCD hearts.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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