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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 NameTENDRIL ST LEAD
Classification Namepulse generator, permanent, implantable
Generic Namecardiovascular permanent pacemaker electrode
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP960013
Supplement NumberS041
Date Received12/09/2008
Decision Date12/31/2008
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change to eliminate the plasma priming process.
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