PMA P230040S015
- Device
- CorPASS System
- Applicant
- Endotronix, Inc.
- PMA number
- P230040
- Supplement
- S015
- Product code
- MOM
- Decision date
- 2025-12-19
- Classification
- Cardiovascular
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- Approval for to modifications in the implanter’s labeling to remove the mandatory Sensor recalibrations every 3 years.
Current openFDA PMA Record#
- Device
- CorPASS System
- Applicant
- Endotronix, Inc.
- PMA number
- P230040
- Supplement
- S015
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2025-12-19
- Decision code
- APPR
- Date received
- 2025-05-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for to modifications in the implanter’s labeling to remove the mandatory Sensor recalibrations every 3 years.