PMA P160013S012

Device: Organ Care System (OCS™) Lung System
Applicant: TransMedics, Inc.
PMA number: P160013
Supplement: S012
Product code: QBA
Decision date: 2023-05-09
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 a change to the wireless monitor of the OCS Lung System, including replacing the obsolete display panel with an updated panel, replacing the existing CCFL backlight driver with an LED backlight driver, updating the Wireless Monitor PCBA with minor component updates.

Current openFDA PMA Record#

Device: Organ Care System (OCS™) Lung System
Applicant: TransMedics, Inc.
PMA number: P160013
Supplement: S012
Product code: QBA
Generic name: Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Decision date: 2023-05-09
Decision code: APPR
Date received: 2023-03-06
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change to the wireless monitor of the OCS Lung System, including replacing the obsolete display panel with an updated panel, replacing the existing CCFL backlight driver with an LED backlight driver, updating the Wireless Monitor PCBA with minor component updates.