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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 LEADS
Classification Namepermanent defibrillator electrodes
Generic Nametransvenous defibrillation lead
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP950022
Supplement NumberS073
Date Received07/13/2010
Decision Date09/09/2010
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval of the post-approval study protocol.
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