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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameQUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS241
Date Received12/05/2012
Decision Date03/20/2014
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional assurity+, assurity, and endurity pacemakers, the allure and allure quadra cardiac resynchronization therapy pacemakers (crt-p), model 3330 version 17. 1. 1 software, and merlin pacing system analyzer (psa) model ex3100.
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