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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 PACING LEADS MODELS 4086, 4087, 4088, AND FIXATIO NTOOL MODEL 6616
Classification Namepermanent pacemaker electrode
Generic Nametransvenous bipolar pacing lead
Regulation Number870.3680
ApplicantGUIDANT CORP.
PMA NumberP960006
Supplement NumberS005
Date Received07/11/2001
Decision Date02/04/2002
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the flextend pacing leads models 4086, 4087, 4088, and fixation tool model 6616. The flextend pacing leads models 4086, 4087, and 4088 are indicated for chronic pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator.
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