PMA
P230040: Cordella Pulmonary Artery Sensor System (CorPASS)
FDA PMA · System, hemodynamic, implantable · Endotronix, Inc.
Key facts
| PMA number | P230040 |
|---|---|
| Trade name | Cordella Pulmonary Artery Sensor System (CorPASS) |
| Generic name | System, hemodynamic, implantable |
| Applicant | Endotronix, Inc. |
| Owner/operator | Endotronix |
| Product code | MOM |
| Approval date | Jun 20, 2024 |
| Docket number | 24M-2925 |
| Notice date | Jun 28, 2024 |
| Establishment registration | 3024985933 |
| FEI number | 3024985933 |
At a glance
- 10–99 Supplements
- Sep 25, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: