PMA supplement
P160013 S001: Organ Care System (OCS™) Lung System
FDA PMA supplement · Normal 180 Day Track No User Fee · TransMedics, Inc.
Key facts
| Original PMA | P160013 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol - OSB |
| 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 | Apr 6, 2018 |
| Decision date | Jun 14, 2018 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: