PMA P160013

Device: Organ Care System (OCS™) Lung System
Applicant: TransMedics, Inc.
PMA number: P160013
Supplement: S009
Product code: QBA
Decision date: 2026-05-13
Generic name: Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Approval order statement: approval for material, supplier, and design changes to the filter cap and raw material and supplier changes to the pleated filter assembly

Current openFDA PMA Record#

Device: Organ Care System (OCS™) Lung System
Applicant: TransMedics, Inc.
PMA number: P160013
Supplement: S021
Product code: QBA
Generic name: Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Decision date: 2026-05-13
Decision code: APPR
Date received: 2025-12-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for material, supplier, and design changes to the filter cap and raw material and supplier changes to the pleated filter assembly