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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) Heart System
Generic NameOrgan care system (OCS) heart system
ApplicantTransMedics, Inc.
200 Minuteman Rd.
Suite 302
Andover, MA 01810
PMA NumberP180051
Supplement NumberS007
Date Received09/24/2024
Decision Date10/23/2024
Product Code QIK 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to change the supplier for the reservoir filter component of the Organ Care System Heart Perfusion module
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