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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 NameGUIDANT CONTAK RENEWAL TR MODELS H125 AND H120
Classification Namepermanent pacemaker electrode
Generic Namecardiac resynchronization therapy pacemaker (crt-p)
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP030005
Supplement NumberS005
Date Received11/22/2004
Decision Date03/08/2005
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modified device labeling to describe the companion clinical study.
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