PMA P230040S012
- Device
- Cordella Pulmonary Artery Sensor System (CorPASS)
- Applicant
- Endotronix, Inc.
- PMA number
- P230040
- Supplement
- S012
- Product code
- MOM
- Decision date
- 2025-06-20
- Classification
- Cardiovascular
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- an alternate reader, Reader Alloy, in the Cordella Pulmonary Artery Sensor System.
Current openFDA PMA Record#
- Device
- Cordella Pulmonary Artery Sensor System (CorPASS)
- Applicant
- Endotronix, Inc.
- PMA number
- P230040
- Supplement
- S012
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2025-06-20
- Decision code
- APPR
- Date received
- 2025-03-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- an alternate reader, Reader Alloy, in the Cordella Pulmonary Artery Sensor System.