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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 PRESSURE MEASUREMENT 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 NumberS002
Date Received11/26/2014
Decision Date07/10/2015
Product Code
MOM[ Registered Establishments with MOM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
APPROVAL FOR THE NEXT GENERATION OF HOME USE ELECTRONICS, THE I3 PATIENT ELECTRONICS.
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