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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)
Applicant
Abbott Medical
15900 valley view court
sylmar, CA 91335
PMA NumberP030035
Supplement NumberS149
Date Received08/30/2016
Decision Date09/27/2016
Product Code NKE 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of an automated test solution for hybrid assemblies.
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