PMA P160013S020

Device: Organ Care System™ (OCS™) Lung System
Applicant: TransMedics, Inc.
PMA number: P160013
Supplement: S020
Product code: QBA
Decision date: 2025-12-16
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 in the pressure test condition in the inline leak test performed during assembly.

Current openFDA PMA Record#

Device: Organ Care System™ (OCS™) Lung System
Applicant: TransMedics, Inc.
PMA number: P160013
Supplement: S020
Product code: QBA
Generic name: Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Decision date: 2025-12-16
Decision code: APPR
Date received: 2025-11-25
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a change in the pressure test condition in the inline leak test performed during assembly.