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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
Generic NameSystem, hemodynamic, implantable
ApplicantABBOTT MEDICAL
387 Nerem St. NW
Suite #500
Atlanta, GA 30313
PMA NumberP100045
Supplement NumberS065
Date Received03/31/2023
Decision Date04/28/2023
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  
Approval for labeling changes being made to the users manual or system guides with updated electromagnetic compatibility (EMC) information.
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