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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 AND PROTECTA XT,VIVA XT,VIVA S,BRAVA CRT-DS
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS499
Date Received03/06/2015
Decision Date05/04/2015
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 FIRMWARE UPDATES TO THE MEDTRONIC MODEL 25000 MYCARELINK SMART READER FOR USE WITH THE DEVICES.
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