PMA P200031S001

Device: Organ Care System (OCS®) Liver™
Applicant: TransMedics, Inc.
PMA number: P200031
Supplement: S001
Product code: QQK
Decision date: 2022-09-19
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: Approval of revised device labeling to reflect the final results of the OCS Liver PROTECT Continuation Post-Approval Study.

Current openFDA PMA Record#

Device: Organ Care System (OCS®) Liver™
Applicant: TransMedics, Inc.
PMA number: P200031
Supplement: S001
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2022-09-19
Decision code: APPR
Date received: 2022-04-08
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval of revised device labeling to reflect the final results of the OCS Liver PROTECT Continuation Post-Approval Study.