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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/FINELINE ENDOCARDIAL PACING LEADS
Classification Namepermanent pacemaker electrode
Generic Nameimplantable endocardial pacemaker lead
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP960004
Supplement NumberS011
Date Received01/11/2000
Decision Date02/23/2000
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to market all previously marketed intermidics shylets kits under new guidant modelnumbers and provide an alternate stylet kit package insert.
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