PMA P160013S010

Device: Organ Care System (OCS™) Lung System
Applicant: TransMedics, Inc.
PMA number: P160013
Supplement: S010
Product code: QBA
Decision date: 2023-02-24
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Approval order statement: Approval for revised labeling to reflect the final results of INSPIRE, Lung EXPAND and Lung EXPAND II clinical trials.

Current openFDA PMA Record#

Device: Organ Care System (OCS™) Lung System
Applicant: TransMedics, Inc.
PMA number: P160013
Supplement: S010
Product code: QBA
Generic name: Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Decision date: 2023-02-24
Decision code: APPR
Date received: 2022-08-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for revised labeling to reflect the final results of INSPIRE, Lung EXPAND and Lung EXPAND II clinical trials.