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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceENTRUST ICD AND THE CARDIOSIGHT READER
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS105
Date Received06/19/2006
Decision Date07/12/2006
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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