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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 NameATLAS II + HF CRT-D SYSTEM
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantST. JUDE MEDICAL
PMA NumberP030054
Supplement NumberS067
Date Received09/05/2007
Decision Date01/13/2009
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the st. Jude medical sj4 quadripolar defibrillation system consisting of device models atlas ii+hf v366q and promote 3107-36q; lead models riata st optim 7020q, 7021q, 7022q, and riata sts optim 7120q, 7121q, 7122q; and programmer models sjm 3510 and merlin 3650.
Post-Approval StudyShow Report Schedule and Study Progress
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