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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 SJ4/DF4 FAMILIES OF HIGH VOLTAGE LEADS
Classification Namepermanent defibrillator electrodes
Generic Nametransvenous defibrillation lead
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP950022
Supplement NumberS075
Date Received10/21/2010
Decision Date12/06/2010
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the molded connector subassembly for improved manufacturability and reduced cost for the durata sj4 and df4 high voltage leads. Changes include minor design, material, and manufacturing process changes. Additionally, the current approved supplier, accellent, will be performing all manufacturing operations related to the molded connector subassembly.
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