PMA P200031S014

Device: Organ Care System (OCS™) Liver
Applicant: TransMedics, Inc.
PMA number: P200031
Supplement: S014
Product code: QQK
Decision date: 2026-03-09
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: the revised labeling that reflects the final results of the OCS Liver Perfusion (OLP) Registry post-approval study

Current openFDA PMA Record#

Device: Organ Care System (OCS™) Liver
Applicant: TransMedics, Inc.
PMA number: P200031
Supplement: S014
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2026-03-09
Decision code: APPR
Date received: 2025-12-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: the revised labeling that reflects the final results of the OCS Liver Perfusion (OLP) Registry post-approval study