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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, Claria MRI/Quad, Compia MRI/Quad, Consulta, Protecta/XT, Viava Quad S/XT, Viva S/XT CRT-D
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP010031
Supplement NumberS677
Date Received07/12/2019
Decision Date08/06/2019
Product Code NIK 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Implementation of process controls for Soft Straight-Line Finish (SLF) cosmetic work.
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