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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 Technology Circle, NW
Suite 500
Atlanta, GA 30313
PMA NumberP100045
Supplement NumberS028
Date Received01/29/2018
Decision Date02/26/2018
Product Code MOM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Addition of second supplier for the catheter sub-assembly of the Pulmonary Artery (PA) Delivery catheter.
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