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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.
 
DeviceREVEAL LINQ SOFTWARE MODEL SWO26
Generic NamePacemaker/icd/crt non-implanted components
ApplicantMedtronic, Inc.
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP890003
Supplement NumberS304
Date Received03/05/2014
Decision Date04/30/2014
Product Code OSR 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MODEL SW026 APPLICATION SOFTWARE FOR THE REVEAL LINQ IMPLANTABLE CARDIAC MONITORS USED ON THE MODEL 2090 AND ENCORE PROGRAMMERS.
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