Cordella Pulmonary Artery Sensor System (CorPASS)
FDA premarket approval P230040/S001 · decided 2024-10-04
Approval details
- PMA number
- P230040
- Supplement
- S001
- 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
- 2024-07-19
- Decision date
- 2024-10-04
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Naperville, IL
- Statement
- of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230040
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