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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 NumberS019
Date Received01/10/2017
Decision Date05/19/2017
Product Code
MOM[ Registered Establishments with MOM ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for hardware and software updates to equipment used to measure atmospheric and device parameters used in-process during production.
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