PMA P200031S013

Device: Organ Care System (OCS™) Liver
Applicant: TransMedics, Inc.
PMA number: P200031
Supplement: S013
Product code: QQK
Decision date: 2026-05-13
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: approval for material, supplier, and design changes to the filter cap and raw material and supplier changes to the pleated filter assembly

Current openFDA PMA Record#

Device: Organ Care System (OCS™) Liver
Applicant: TransMedics, Inc.
PMA number: P200031
Supplement: S013
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2026-05-13
Decision code: APPR
Date received: 2025-12-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for material, supplier, and design changes to the filter cap and raw material and supplier changes to the pleated filter assembly