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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 NameDURATA LEAD MODELS
Classification Namepermanent defibrillator electrodes
Generic Nametransvenous defibrillation lead
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP950022
Supplement NumberS060
Date Received05/14/2009
Decision Date07/10/2009
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for passive fixation durata leads with sj4 four-pole proximal connectors; model numbers 7170q and 7171q.
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