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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 NumberS052
Date Received04/01/2021
Decision Date11/23/2021
Product Code MOM 
Advisory Committee Cardiovascular
Clinical TrialsNCT00531661
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for final labeling for the CardioMEMS HF System.
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