PMA supplement
P160013 S002: Organ Care System (OCS™) Lung System
FDA PMA supplement · Panel Track · TransMedics, Inc.
Key facts
| Original PMA | P160013 |
|---|---|
| Supplement number | S002 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| 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. |
| Product code | QBA |
| Received date | Aug 14, 2018 |
| Decision date | May 31, 2019 |
| Docket number | 19M-2671 |
| Notice date | Jun 4, 2019 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: