PMA P160013S014

Device: Organ Care System™ (OCS™) Lung
Applicant: TransMedics, Inc.
PMA number: P160013
Supplement: S014
Product code: QBA
Decision date: 2023-06-28
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Approval order statement: Change the supplier for the vented bag component of the OCS Perfusion module.

Current openFDA PMA Record#

Device: Organ Care System™ (OCS™) Lung
Applicant: TransMedics, Inc.
PMA number: P160013
Supplement: S014
Product code: QBA
Generic name: Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Decision date: 2023-06-28
Decision code: OK30
Date received: 2023-06-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change the supplier for the vented bag component of the OCS Perfusion module.