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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.
 
DeviceQuickflex u, Quartet Cardiac Resynchronization Therapy Passive
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
Abbott Medical
15900 valley view court
sylmar, CA 91335
PMA NumberP030054
Supplement NumberS367
Date Received11/30/2018
Decision Date12/17/2018
Product Code NIK 
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 
Acquire curing trays and Teflon coating services from alternate suppliers for use in the curing process when creating Optim E2A resin pellets.
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