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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 NumberS005
Date Received09/23/2024
Decision Date10/03/2024
Product Code MOM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to implement an automated test system for incoming inspection of the Docking Station PCB
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