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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 CRT-D, Claria MRI Quad CRT-D, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI 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 NumberS728
Date Received12/09/2020
Decision Date04/01/2021
Product Code NIK 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the proposed clinical study summary labeling for the Multiple Point Pacing (MPP) Post Approval Clinical Study.
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