Organ Care System (OCS™) Liver

FDA Premarket Approval P200031

Pre-market Approval Supplement Details

Approval for organ care system (ocs) liver for the indication of: the transmedics® organ care system (ocs) liver is a portable extracorporeal liver perfusion and monitoring system indicated for preservation and monitoring of hemodynamics and metabolic function which allows for ex-vivo assessment of liver allografts from donors after brain death (dbd) or liver allografts from donors after circulatory death (dcd)

DeviceOrgan Care System (OCS™) Liver
Generic NameNormothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
ApplicantTransMedics, Inc.
Date Received2020-06-30
Decision Date2021-09-28
PMAP200031
SupplementS
Product CodeQQK 
Advisory CommitteeGastroenterology/Urology
Expedited ReviewNo
Combination Product No
Applicant Address TransMedics, Inc. 200 Minuteman Road suite 302 andover, MA 01810

Supplemental Filings

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Supplement NumberDateSupplement Type
P200031Original Filing

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