PMA P230040S035

Device
Cordella Pulmonary Artery Sensor System (CorPASS)
Applicant
Endotronix, Inc.
PMA number
P230040
Supplement
S035
Product code
MOM
Decision date
2026-10-20
Classification
Cardiovascular
Generic name
System, hemodynamic, implantable
Approval order statement
removal of a redundant inspection process of the Coil PCB subassemblies

Current openFDA PMA Record#

Device
Cordella Pulmonary Artery Sensor System (CorPASS)
Applicant
Endotronix, Inc.
PMA number
P230040
Supplement
S035
Product code
MOM
Generic name
System, hemodynamic, implantable
Decision date
2026-10-20
Decision code
OK30
Date received
2026-09-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
removal of a redundant inspection process of the Coil PCB subassemblies