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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 NameVENTAK AND CONTAK CD FAMILIES OF ICDS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator
ApplicantGUIDANT CORP.
PMA NumberP010012
Supplement NumberS116
Date Received03/06/2006
Decision Date04/12/2006
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the labeling for the ventak (p960040) and contak cd (p010012) families of implantable defibrillators to include information regarding behavior of these devices attributable to the svo (silver vanadium oxide) used to power them. Specifically, an update to the system guide to include language to identify as normal an increased charged time in midlife due to the inherent characteristics of the svo batteries used.
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