PMA P230040S028

Device
Cordella Pulmonary Artery Sensor System (CorPASS)
Applicant
Endotronix, Inc.
PMA number
P230040
Supplement
S028
Product code
MOM
Decision date
2026-02-24
Classification
Cardiovascular
Generic name
System, hemodynamic, implantable
Approval order statement
use of faraday cages to improve production efficacy

Current openFDA PMA Record#

Device
Cordella Pulmonary Artery Sensor System (CorPASS)
Applicant
Endotronix, Inc.
PMA number
P230040
Supplement
S028
Product code
MOM
Generic name
System, hemodynamic, implantable
Decision date
2026-02-24
Decision code
OK30
Date received
2026-01-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
use of faraday cages to improve production efficacy