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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 IPG AND PACING SYSTEM
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP090013
Supplement NumberS220
Date Received03/01/2016
Decision Date08/24/2016
Product Codes NVN LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the expansion of MRI conditional labeling for the Amplia MRI and Compia MRI Systems to include 3T MRI.
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