PMA P230040S019
- Device
- Cordella Pulmonary Artery Sensor System (CorPASS)
- Applicant
- Endotronix, Inc.
- PMA number
- P230040
- Supplement
- S019
- Product code
- MOM
- Decision date
- 2025-09-10
- Classification
- Cardiovascular
- Generic name
- System, hemodynamic, implantable
- Approval order statement
- to use an alternate cutting method for platinum tubing in Implant Marker Bands
Current openFDA PMA Record#
- Device
- Cordella Pulmonary Artery Sensor System (CorPASS)
- Applicant
- Endotronix, Inc.
- PMA number
- P230040
- Supplement
- S019
- Product code
- MOM
- Generic name
- System, hemodynamic, implantable
- Decision date
- 2025-09-10
- Decision code
- OK30
- Date received
- 2025-08-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to use an alternate cutting method for platinum tubing in Implant Marker Bands