PMA P230040S020

Device
Cordella Pulmonary Artery Sensor System (CorPASS)
Applicant
Endotronix, Inc.
PMA number
P230040
Supplement
S020
Product code
MOM
Decision date
2025-09-30
Classification
Cardiovascular
Generic name
System, hemodynamic, implantable
Approval order statement
introducing a modified capacitor trim model

Current openFDA PMA Record#

Device
Cordella Pulmonary Artery Sensor System (CorPASS)
Applicant
Endotronix, Inc.
PMA number
P230040
Supplement
S020
Product code
MOM
Generic name
System, hemodynamic, implantable
Decision date
2025-09-30
Decision code
OK30
Date received
2025-09-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
introducing a modified capacitor trim model