PMA supplement
P230040 S011: Cordella Pulmonary Artery Sensor System (CorPASS)
FDA PMA supplement · Real-Time Process · Endotronix, Inc.
Key facts
| Original PMA | P230040 |
|---|---|
| Supplement number | S011 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Cordella Pulmonary Artery Sensor System (CorPASS) |
| Generic name | System, hemodynamic, implantable |
| Applicant | Endotronix, Inc. |
| Product code | MOM |
| Received date | Mar 19, 2025 |
| Decision date | Jun 25, 2025 |
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: