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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.
 
DeviceKAPPA 400 FAMILY OF PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 Coral Sea Street NE
Mounds View, MN 55112
PMA NumberP970012
Supplement NumberS021
Date Received02/14/2006
Decision Date03/31/2006
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/BOSS (SOFTWARE VERSION 1.5.1) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL MEDTRONIC PACEMAKER AND ICD MODELS. IT IS TO ENHANCE INTERNAL
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