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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
Classification Namesystem, hemodynamic, implantable
Generic Namesystem, hemodynamic, implantable
Applicant
St. Jude Medical
387 technology circle nw
suite 500
atlanta, GA 30313
PMA NumberP100045
Supplement NumberS035
Date Received10/29/2018
Decision Date03/13/2019
Product Code
MOM[ Registered Establishments with MOM ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software modification to the Merlin.net MN6000 HF Web Application v10.0 software.
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