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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.
Classification Namepermanent pacemaker electrode
Generic Namepermanent pacemaker electrode
Regulation Number870.3680
4100 hamline avenue north
st. paul, MN 55112
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 - indications/instructions/shelf life/tradename
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.