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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 NameTHINLINE II STEROX /FINELINE II STEROX ENDOCARDIAL PACING LEADS
Classification Namepermanent pacemaker electrode
Generic Nameactive fixation transvenous bipolar pacing lead
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP960004
Supplement NumberS022
Date Received06/03/2003
Decision Date07/02/2003
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a biocompatible adhesive to the lead which will enhance the ability to maintain the position of the drug-eluting collar at its designed location.
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