PMA P230040S014
- Device
- Cordella Pulmonary Artery Sensor System (CorPASS)
- Applicant
- Endotronix, Inc.
- PMA number
- P230040
- Supplement
- S014
- Product code
- MOM
- Decision date
- 2025-05-13
- Classification
- Cardiovascular
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- implement alternate manufacturing equipment for Silicon dicing at a component supplier
Current openFDA PMA Record#
- Device
- Cordella Pulmonary Artery Sensor System (CorPASS)
- Applicant
- Endotronix, Inc.
- PMA number
- P230040
- Supplement
- S014
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2025-05-13
- Decision code
- OK30
- Date received
- 2025-04-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implement alternate manufacturing equipment for Silicon dicing at a component supplier