Cordella Pulmonary Artery Sensor System (CorPASS)
FDA premarket approval P230040/S007 · decided 2025-02-03
Approval details
- PMA number
- P230040
- Supplement
- S007
- 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
- 2024-11-04
- Decision date
- 2025-02-03
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Naperville, IL
- Statement
- the Reader Bluetooth module, real-time clock, and other discrete electrical components
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