Cordella Pulmonary Artery Sensor System (CorPASS)
FDA premarket approval P230040/S010 · decided 2025-01-17
Approval details
- PMA number
- P230040
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Cordella Pulmonary Artery Sensor System (CorPASS)
- Generic name
- System, hemodynamic, implantable
- Applicant
- Endotronix, Inc.
- Date received
- 2024-12-18
- Decision date
- 2025-01-17
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Naperville, IL
- Statement
- the post-approval enrollment timelines
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