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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 and 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 NumberS176
Date Received11/20/2018
Decision Date12/11/2018
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  
Add Stereo as an alternate supplier of 100% ethylene oxide gas.
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