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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 MONITOR MODEL 2490H
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS119
Date Received05/10/2007
Decision Date05/13/2008
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 THE MEDTRONIC ADAPTA/VERSA/SENSIA IMPLANTABLE PACEMAKERS (A/V/S PACEMAKERS), MODEL SW003 APPLICATION SOFTWARE, AND MODEL 2490H MEDTRONIC CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE.
Post-Approval StudyShow Report Schedule and Study Progress
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