PMA P230040S027

Device
Cordella Pulmonary Artery Sensor System (CorPASS)
Applicant
Endotronix, Inc.
PMA number
P230040
Supplement
S027
Product code
MOM
Decision date
2026-02-17
Classification
Cardiovascular
Generic name
System, hemodynamic, implantable
Approval order statement
the replacement of four obsolete components within the Multi-Cell (MC) Battery Pack

Current openFDA PMA Record#

Device
Cordella Pulmonary Artery Sensor System (CorPASS)
Applicant
Endotronix, Inc.
PMA number
P230040
Supplement
S027
Product code
MOM
Generic name
System, hemodynamic, implantable
Decision date
2026-02-17
Decision code
OK30
Date received
2026-01-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
the replacement of four obsolete components within the Multi-Cell (MC) Battery Pack