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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.
 
DeviceLEGEND PLUS FAMILY OF PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 Coral Sea Street NE
Mounds View, MN 55112
PMA NumberP930022
Supplement NumberS011
Date Received03/01/2010
Decision Date05/11/2010
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 ENHANCEMENTS TO THE MODEL 9986 SOFTWARE. THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
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