PMA P200031S007

Device: Organ Care System (OCS™) Liver
Applicant: TransMedics, Inc.
PMA number: P200031
Supplement: S007
Product code: QQK
Decision date: 2025-01-13
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: Approval for the implementation of an alternative oxygenator, identified as the Maquet Quadrox-i, for the Organ Care System Liver

Current openFDA PMA Record#

Device: Organ Care System (OCS™) Liver
Applicant: TransMedics, Inc.
PMA number: P200031
Supplement: S007
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2025-01-13
Decision code: APPR
Date received: 2024-07-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the implementation of an alternative oxygenator, identified as the Maquet Quadrox-i, for the Organ Care System Liver