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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.
 
DeviceBrava CRT-D, Brava Quad CRT-D, Viva Quad CRT-D, Viva Quad S/XT CRT-D, and 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 NumberS683
Date Received10/15/2019
Decision Date12/16/2019
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for RAMware updates to ICD and CRT-D devices and corresponding updates to the Medtronic CareLink 2090 Programmer Model SW016 and CareLink Encore 29901 Programmer Model SW033.
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