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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 NameCONCERT II, CONSULTA, & MAXIMO II CRT-DS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS296
Date Received03/07/2012
Decision Date06/04/2012
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for concerto ii crt-d model d274trk, consulta crt-d models d204trm and d224trk and maximo ii crt-d models d264trm and d284trk.
Approval Order Approval Order
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