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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 NameSELUTE
Classification Namepermanent defibrillator electrodes
Generic Namealternate endocardial lead stabilizer component
ApplicantGUIDANT CORP.
PMA NumberP950001
Supplement NumberS016
Date Received04/13/2006
Decision Date05/11/2006
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Changes to the limulus amebocyte lysate (lal) sampling plan.
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