CorPASS System
FDA premarket approval P230040/S015 · decided 2025-12-19
Approval details
- PMA number
- P230040
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CorPASS System
- Generic name
- System, hemodynamic, implantable
- Applicant
- Endotronix, Inc.
- Date received
- 2025-05-02
- Decision date
- 2025-12-19
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- MOM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Naperville, IL
- Statement
- Approval for to modifications in the implanterÂ’s labeling to remove the mandatory Sensor recalibrations every 3 years.
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