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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 LEADS MODELS 1788 & 1782
Classification Namepulse generator, permanent, implantable
Generic Namecardiovascular permanent pacemaker electrode
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP960013
Supplement NumberS033
Date Received05/11/2007
Decision Date06/26/2007
Product Code
NVZ
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for ring electrode modifications to tendril 1788 and 1782 leads, and an outer insulation tube diameter change for tendril 1782 leads.
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