Premarket Approval (PMA)

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.

• Device: OCS Heart System
• Generic Name: Organ care system (OCS) heart system
• Applicant: TransMedics, Inc.; 200 Minuteman Road, Suite 302; Andover, MA 01810
• PMA Number: P180051
• Supplement Number: S001
• Date Received: 11/08/2021
• Decision Date: 04/27/2022
• Product Code: QIK
• Docket Number: 22M-0715
• Notice Date: 05/03/2022
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT03831048
• Supplement Type: Panel 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) 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 Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress