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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.
 
DeviceCONSULTA CRT D,MAXIMO II CRT-D,CONCERTO II CRT-D,CONCERTO CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA XT CRT-D,VIVA S
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 NumberS376
Date Received05/13/2013
Decision Date07/15/2013
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR CELLULAR CONNECTIVITY FOR REMOTE MONITORING WITH MODEL 2020A CARDIOSIGHT READER AND MODELS 2020B, 2020C MEDTRONIC CARELINK EXPRESS MONITORS.
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