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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 NumberP960006
Supplement NumberS016
Date Received07/05/2005
Decision Date08/04/2005
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Addition of primer to the inner surface of the electrode ring of the flextend leads to increase adhesion of the electrode ring to the molded neck.