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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.
 
DeviceCardioMEMS HF System; Merlin.net PCN HF Portal (Model MN6000); CardioMEMS Backend Web Application (Model CM4000); HF Clo
Generic NameSystem, hemodynamic, implantable
ApplicantABBOTT MEDICAL
387 Nerem St. NW
Suite #500
Atlanta, GA 30313
PMA NumberP100045
Supplement NumberS091
Date Received07/02/2026
Decision Date09/30/2026
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  
proposed modifications to the Merlin.net Patient Care Network (PCN) Heart Failure (HF) Portal (Model MN6000) and the CardioMEMS Backend Web Application (Model CM4000), that comprise the HF Cloud Software Version C2.1 update.
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