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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, CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II DF
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS322
Date Received07/23/2012
Decision Date08/20/2012
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing lines in a new extension of a controlled environment area.
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