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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 NumberS025
Date Received10/12/2017
Decision Date01/05/2018
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
RecallsCDRH Recalls
Approval Order Statement  
Approval for the addition of a cover for the back of the i3 Patient Electronics System.
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