Identity
- Trade Name
- Organ Care System (OCS) Lung System FDA PMA
- Generic Name
- Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation FDA PMA
Identifiers
- PMA Number
- P160013 FDA PMA
- FDA Product Code
- QBA FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Organ Care System (OCS) Lung System is a normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation. It maintains donor lungs in a near physiologic, ventilated, and perfused state to support double lung transplantation procedures.
The system is supplied by TransMedics, Inc. and is indicated for use in preserving donor lungs under near-physiologic conditions. It is a Class III device authorized under FDA PMA (P160013) and is intended for use in clinical transplant settings to optimize lung viability before implantation.
Frequently asked questions
What is the Organ Care System (OCS) Lung System used for?
The Organ Care System (OCS) Lung System is used to preserve standard criteria donor lungs in a near physiologic, ventilated, and perfused state prior to double lung transplantation, as stated in its approval documentation.
Who manufactures the Organ Care System (OCS) Lung System?
The Organ Care System (OCS) Lung System is manufactured by TransMedics, Inc., as specified in the device data under manufacturer and applicant fields.
What regulatory authorization does the Organ Care System (OCS) Lung System have?
The Organ Care System (OCS) Lung System has FDA PMA authorization, specifically under PMA number P160013, as indicated in the AUTHORIZATIONS and openfda fields.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P160013 | Class III | Active |
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Manufacturer
- Manufacturer
- TransMedics, Inc
- FDA Applicant
- TransMedics, Inc.
Sources (1)
- FDA PMA P160013 24 fields · synced Sep 18, 2026