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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 ICD, II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD,INSYNC MAXIMO ICD, II CRT-D,PROTECTA CRT-D, PROTECTA XT CRT-D
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS315
Date Received06/19/2012
Decision Date01/03/2013
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to update the device labeling with the results from the right ventricular lead integrity alert (rv lia) post-approval study (pas).
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