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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.
 
DeviceINSYNC II PROTECT ICD, INSYNC III MARQUIS ICD,INSYNC MARQUIS ICD,INSYNC MAXIMO ICD,BRAVA CRT-D,CONCERTO ICD,CONCERTO II
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS416
Date Received12/19/2013
Decision Date02/27/2014
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR SOFTWARE CHANGES TO THE MYCARELINK PATIENT MONITOR M2.5 MODEL 24950 WITH MODEL 24955 RF HEAD WHICH SUPPORTS THE DEVICES AND MEDTRONIC¿S REVEAL INSERTABLE CARDIAC MONITORS MODELS 9529, 9528 AND LNQ11. THE MYCARELINK PATIENT MONITOR IS INDICATED FOR TRANSMISSION OF IMPLANTABLE DEVICE DATA TO THE CARELINK NETWORK FOR THE CLINIC TO REVIEW.
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