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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, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D,
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS323
Date Received07/25/2012
Decision Date08/17/2012
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
New pressure test equipment used to verify hermeticity.
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