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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 SDX
Classification Namepermanent pacemaker electrode
Generic Namecardiovascular permanent pacemaker electrode
Regulation Number870.3680
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP960013
Supplement NumberS009
Date Received11/16/2000
Decision Date12/07/2000
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following modifications to the suture sleeves used with the pacemaker leads: the incorporation of titanium dioxide into the suture sleeve material to make the material "more visible during implant"; increasing the inner diameter of the sleeve and; removel of the sleeve eyelet's.
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