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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.
 
DeviceCONCERTO/CONCERTO II/INSYNC III MARQUIS/ INSYNC MAXIMO/MAXIMOII/PROTECTA/PROTECTA XT/PROTECTA 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 NumberS284
Date Received11/21/2011
Decision Date02/28/2013
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE CONCERTO, CONCERTO II, CONSULTA, INSYNC III MARQUIS, INSYNC MAXIMO, MAXIMO II, PROTECTA, AND PROTECTA XT CRT-DS.
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