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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 NameTENDRILL PASSIVE PLUS/AU PLUS DX
Classification Namepermanent pacemaker electrode
Generic Namepermanent pacemaker electrode
Regulation Number870.3680
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP960030
Supplement NumberS008
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 matgerial to make the material "more visible during implant"; increasing the inner diameter of the sleeve and; removal of the sleeve eyelet's.
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