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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 NumberS026
Date Received01/16/2026
Decision Date02/13/2026
Product Code MOM 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the removal of the current warning requiring continuous systemic heparin infusion and ACT 200 seconds during implantation and replaced it with a precaution recommending periodic flushing of the Delivery System side port with saline.
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