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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/Quad, Brava/Quad CRT-D, Claria MRI/Quad CRT-D, Compia MRI/Quad CRT-D, Consulta CRT-D, Maximo II CRT-D, Vivad
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 NumberS598
Date Received06/23/2017
Decision Date07/18/2017
Product Code NIK 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Update the manufacturing execution system (MES) to FACTORYworks (FW) Release 9.3 at Medtronic Swiss Manufacturing Operations.
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