Cordella Pulmonary Artery Sensor System (CorPASS)
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Cordella Pulmonary Artery Sensor System (CorPASS) FDA PMA
- Generic Name
- System, hemodynamic, implantable FDA PMA
Identifiers
- PMA Number
- P230040 FDA PMA
- FDA Product Code
- MOM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Cordella Pulmonary Artery Sensor System (CorPASS) is an implantable hemodynamic system designed to measure, record, and transmit pulmonary artery pressure (PAP) data. It is intended for use in NYHA Class III heart failure patients who are stable on guideline-directed medical therapy and diuretics.
The system is supplied as an implantable device for home use, transmitting data to aid clinicians in assessing and managing heart failure with the goal of reducing hospitalizations. It is authorized under FDA PMA P230040 and classified as a Class III implantable hemodynamic system.
Frequently asked questions
What is the Cordella Pulmonary Artery Sensor System (CorPASS) intended to measure?
The Cordella Pulmonary Artery Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients who are at home on diuretics and guideline-directed medical therapy and have been stable for 30 days on GDMT.
Who manufactures the Cordella Pulmonary Artery Sensor System (CorPASS)?
The Cordella Pulmonary Artery Sensor System (CorPASS) is manufactured by Endotronix, Inc., located in Naperville, Illinois.
What regulatory authorization does the Cordella Pulmonary Artery Sensor System (CorPASS) have?
The Cordella Pulmonary Artery Sensor System (CorPASS) has received FDA Premarket Approval (PMA) under application number P230040, with a decision date of June 20, 2024.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P230040 | Class III | Active |
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Manufacturer
- Manufacturer
- Endotronix, Inc.
Sources (1)
- FDA PMA P230040 24 fields · synced Oct 6, 2026