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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.
 
DeviceAllure, Allure Quadra, Quadra Allure MP
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantAbbott Medical
15900 valley view court
sylmar, CA 91335
PMA NumberP030035
Supplement NumberS163
Date Received12/07/2017
Decision Date01/03/2018
Product Code NKE 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Use of an additional solder material allowing for the rework of pacemaker and CRT-P hybrid circuits.
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