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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 & DF4 ICD, CONSULTA ICD, INSYNC II MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS342
Date Received11/21/2012
Decision Date12/20/2012
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of the manufacturing execution system version 7. 9 at various internal suppliers and final device manufacturing locations.
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