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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 II/MAXIMO II/CONSULTA/CONCERTO CRT-DS/INSYNC MAXIMO/SENTRY/INSYNC II MARQUIS/INSYNC III MARQUIS ICDS
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS231
Date Received01/18/2011
Decision Date02/17/2011
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of a detection step in the battery manufacturing process at a supplier.
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