PMA P200031S010

Device: Organ Care System™ (OCS™) Liver
Applicant: TransMedics, Inc.
PMA number: P200031
Supplement: S010
Product code: QQK
Decision date: 2025-07-01
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: approval for modifications to the organ chamber hepatic artery (HA) and portal vein (PV) connectors of the OCS Liver System to support improved manufacturability of the organ chamber

Current openFDA PMA Record#

Device: Organ Care System™ (OCS™) Liver
Applicant: TransMedics, Inc.
PMA number: P200031
Supplement: S010
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2025-07-01
Decision code: APPR
Date received: 2024-09-26
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for modifications to the organ chamber hepatic artery (HA) and portal vein (PV) connectors of the OCS Liver System to support improved manufacturability of the organ chamber