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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.
 
DeviceAmplia MRI SureScan Model DTMB1D4, Amplia MRI Quad SureScan Model DTMB1QQ, Compia MRI SureScan Model DTMC1D4, Compia MR
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS540
Date Received03/11/2016
Decision Date09/07/2016
Product Code NIK 
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 1.5 and 3T MR-conditional labeling for MRI SureScan lead Models 4074, 4574, and 4076 when used with currently approved SureScan MR-conditional devices.
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