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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.
 
DeviceANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-P'S
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantAbbott Medical
15900 valley view court
sylmar, CA 91335
PMA NumberP030035
Supplement NumberS147
Date Received04/26/2016
Decision Date07/25/2016
Product Code NKE 
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for software modifications to the Merlin.net MN6000 HF Web Application v9.0 software.
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