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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.
 
DeviceREVO MRI SURESCAN PACING SYSTEM
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic, Inc
8200 Coral Sea Street NE
Mounds View, MN 55112
PMA NumberP090013
Supplement NumberS013
Date Received03/29/2011
Decision Date05/27/2011
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR MODEL 2490G (VERSION 9V5) MEDTRONIC CARELINK MONITOR AND MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (REVO MRI SW018 XMLTU AND ENRHYTHM MRI V7.3 SW005 XMLTU).
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