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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 NumberS001
Date Received07/19/2024
Decision Date10/04/2024
Product Code MOM 
Advisory Committee Cardiovascular
Clinical TrialsNCT04089059
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230040
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