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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.
 
DeviceATLAS II + HF CRT-D SYSTEM
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
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/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ST. JUDE MEDICAL SJ4 QUADRIPOLAR DEFIBRILLATION SYSTEMCONSISTING OF DEVICE MODELS ATLAS II+HF V366Q AND PROMOTE 3107-36Q; LEAD MODELS RIATA STOPTIM 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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