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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 LEADS
Classification Namepermanent defibrillator electrodes
Generic Nametransvenous bipolar pacing lead
ApplicantGUIDANT CORP.
PMA NumberP960006
Supplement NumberS019
Date Received11/09/2005
Decision Date12/08/2005
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Addition of a second supplier for the fluoro ring component used for identifying the position of the electrode during fluoroscopy.
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