Cordella Pulmonary Artery Sensor System (CorPASS)
FDA premarket approval P230040/S011 · decided 2025-06-25
Approval details
- PMA number
- P230040
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Cordella Pulmonary Artery Sensor System (CorPASS)
- Generic name
- System, hemodynamic, implantable
- Applicant
- Endotronix, Inc.
- Date received
- 2025-03-19
- Decision date
- 2025-06-25
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Naperville, IL
- Statement
- approval for changes to components in the Handheld Reader Power Board and the Docking Station.
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