PMA
P160013: Organ Care System (OCS™) Lung System
FDA PMA · Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation · TransMedics, Inc.
Key facts
| PMA number | P160013 |
|---|---|
| Trade name | Organ Care System (OCS™) Lung System |
| Generic name | Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation |
| Applicant | TransMedics, Inc. |
| Owner/operator | TransMedics |
| Product code | QBA |
| Approval date | Mar 22, 2018 |
| Docket number | 18M-1237 |
| Notice date | Apr 10, 2018 |
| Establishment registration | 3003152463 |
| FEI number | 3003152463 |
At a glance
- 10–99 Supplements
- May 13, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: