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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 NameRIATA ST OPTIM AND RIATA STS OPTIM
Classification Namepermanent defibrillator electrodes
Generic Nametransvenous defibrillation lead
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP950022
Supplement NumberS042
Date Received09/05/2007
Decision Date01/13/2009
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
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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