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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.
 
DeviceCARELINK HOME MONITOR MODEL 2491
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic, Inc.
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP890003
Supplement NumberS245
Date Received02/27/2012
Decision Date03/22/2012
Product Code LWP 
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 A PROPOSED SOFTWARE CHANGE PERTAINING TO FIVE EXTENSIBLE MARK-UP LANGUAGE TRANSLATION UTILITIES (XMLTU) FOR THE FOLLOWING DEVICE FAMILIES: ENTRUST, ENRHYTHM, REVO MRI, PROTECTA, CONCERTO AND VIRTUOSO.
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