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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCONCERTO/CONCERTO II/INSYNC III MARQUIS/ INSYNC MAXIMO/MAXIMOII/PROTECTA/PROTECTA XT/PROTECTA CRT-D
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS284
Date Received11/21/2011
Decision Date02/28/2013
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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