PMA P160013S002

Device: Organ Care System (OCS™) Lung System
Applicant: TransMedics, Inc.
Product code: QBA
Decision date: 2019-05-31
Generic name: Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Approval order statement: Approval for the Organ Care System (OCS™) Lung System. The TransMedics Organ Care System (OCS) Lung is a portable, normothermic organ perfusion, ventilation and monitoring medical device indicated for preservation of standard criteria donor lung pairs and for preservation of donor lung pairs initially deemed unacceptable for procurement and transplantation based on limitations of cold static preservation. The device allows for ex vivo assessment of donor lungs prior to transplantation.

Current openFDA PMA Record#

Device: Organ Care System (OCS™) Lung System
Applicant: TransMedics, Inc.
PMA number: P160013
Supplement: S002
Product code: QBA
Generic name: Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Decision date: 2019-05-31
Decision code: APPR
Date received: 2018-08-14
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the Organ Care System (OCS™) Lung System. The TransMedics Organ Care System (OCS) Lung is a portable, normothermic organ perfusion, ventilation and monitoring medical device indicated for preservation of standard criteria donor lung pairs and for preservation of donor lung pairs initially deemed unacceptable for procurement and transplantation based on limitations of cold static preservation. The device allows for ex vivo assessment of donor lungs prior to transplantation.