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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 NameENTRUST ICD AND THE CARDIOSIGHT READER
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS105
Date Received06/19/2006
Decision Date07/12/2006
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding support for the concerto model c154dwk and virtuoso models d154awg/ d154vwc to the model 2020a cardiosight readers and the correction of an anomaly in the model 2491 ddma affecting the entrust family of icds.
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