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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 FAMILY OF LEADS
Classification Namepulse generator, permanent, implantable
Generic Namecardiovascular permanent pacemaker electrode
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP960013
Supplement NumberS036
Date Received11/19/2007
Decision Date12/18/2007
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 No
Approval Order Statement 
Extended time between plasma treatment and application of medical adhesive.
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