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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, CONCERTO ICD,CONCERTO II CRT-D,CONSULTA ICD,INSYNC II PROTECT ICD,INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS439
Date Received03/28/2014
Decision Date05/29/2014
Product Codes NIK LWS 
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 MINOR HARDWARE AND FIRMWARE CHANGES TO THE MYCARELINK PATIENT MONITOR MODEL 24955 RF HEAD FOR THE DEVICES.
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