PMA P230040S031

Device: Cordelia™ Pulmonary Artery Pressure Sensor System (CorPASS)
Applicant: Endotronix, Inc.
PMA number: P230040
Supplement: S031
Product code: MOM
Decision date: 2026-10-16
Classification: Cardiovascular
Generic name: System, hemodynamic, implantable
Approval order statement: revisions to the Instructions for Use (IFU) for the Cordelia™ Pulmonary Artery regarding recommendations for guidewire selections

Current openFDA PMA Record#

Device: Cordelia™ Pulmonary Artery Pressure Sensor System (CorPASS)
Applicant: Endotronix, Inc.
PMA number: P230040
Supplement: S031
Product code: MOM
Generic name: System, hemodynamic, implantable
Decision date: 2026-10-16
Decision code: APPR
Date received: 2026-06-25
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: revisions to the Instructions for Use (IFU) for the Cordelia™ Pulmonary Artery regarding recommendations for guidewire selections