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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 µ, Quartet
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
Abbott Medical
15900 valley view court
sylmar, CA 91335
PMA NumberP030054
Supplement NumberS379
Date Received05/22/2020
Decision Date06/18/2020
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 
Inclusion of Abbott SOAL and Abbott RE TEM as alternate test sites; use of a distal subassembly as a surrogate stability test article; and an update to the annual stability protocol.
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