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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 NameFLEXTEND FAMILY OF PACING LEADS
Classification Namepermanent pacemaker electrode
Generic Nametransvenous bipolar pacing lead
Regulation Number870.3680
ApplicantGUIDANT CORP.
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: manufacturing
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.
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