PMA approvals

Cordella Pulmonary Artery Sensor System (CorPASS)

Endotronix, Inc. · System, hemodynamic, implantable · Cardiovascular

P230040 S035SupplementOK30
Open FDA's page for this record
PMA number
P230040
Supplement number
S035
Applicant
Endotronix, Inc.
Street 1
1415 W. Diehl Rd.
Street 2
Suite 500w
City
Naperville
State
IL
Zip
60563
Generic name
System, hemodynamic, implantable
Trade name
Cordella Pulmonary Artery Sensor System (CorPASS)
Product code
MOM
Advisory committee
CV
Advisory committee description
Cardiovascular
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited review flag
N
Date received
2026-09-25
Decision date
2026-10-20
Decision code
OK30
Ao statement
removal of a redundant inspection process of the Coil PCB subassemblies
Harmonized identifiers (openFDA)
Device name
System, Hemodynamic, Implantable
Medical specialty description
Unknown
Device class
3
Registration number
1047843, 2916596, 3005308195, 3038966819, 1048735, 3004936110, 3011706799, 3024985933, 2017865, 3008792657, 3005334138
FEI number
1047843, 2916596, 3005308195, 3038966819, 1048735, 3004936110, 3011706799, 3024985933, 2017865, 3008792657, 3005334138
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.