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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCordella Pulmonary Artery Sensor System (CorPASS)
Generic NameSystem, hemodynamic, implantable
ApplicantEndotronix, Inc.
1415 W. Diehl Rd.
Suite 500w
Naperville, IL 60563
PMA NumberP230040
Supplement NumberS011
Date Received03/19/2025
Decision Date06/25/2025
Product Code MOM 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for changes to components in the Handheld Reader Power Board and the Docking Station.
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