Cordella Pulmonary Artery Sensor System (CorPASS)
FDA premarket approval P230040 · decided 2024-06-20
Approval details
- PMA number
- P230040
- Trade name
- Cordella Pulmonary Artery Sensor System (CorPASS)
- Generic name
- System, hemodynamic, implantable
- Applicant
- Endotronix, Inc.
- Date received
- 2023-12-13
- Decision date
- 2024-06-20
- Days to decision
- 190 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Naperville, IL
- Statement
- The Cordella Pulmonary Artery Sensor System 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 (GDMT) as well as have been stable for 30 days on GDMT. The device output is meant to aid clinicians in the assessment and management of heart failure, with the goal of reducing heart failure hospitalizations.
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