FDA.reportPublic FDA data

PMA P230040S026

Device
Cordella Pulmonary Artery Sensor System (CorPASS)
Applicant
Endotronix, Inc.
PMA number
P230040
Supplement
S026
Product code
MOM
Decision date
2026-02-13
Classification
Cardiovascular
Generic name
System, hemodynamic, implantable
Approval order statement
the removal of the current warning requiring continuous systemic heparin infusion and ACT 200 seconds during implantation and replaced it with a precaution recommending periodic flushing of the Delivery System side port with saline.

Current openFDA PMA Record#

Device
Cordella Pulmonary Artery Sensor System (CorPASS)
Applicant
Endotronix, Inc.
PMA number
P230040
Supplement
S026
Product code
MOM
Generic name
System, hemodynamic, implantable
Decision date
2026-02-13
Decision code
APPR
Date received
2026-01-16
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
the removal of the current warning requiring continuous systemic heparin infusion and ACT 200 seconds during implantation and replaced it with a precaution recommending periodic flushing of the Delivery System side port with saline.