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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 NameMAXIMO II CRT-D/CONCERTO ICD/CONSULTA CRT-D/INSYNC III MARQUIS/PROTECT/INSYNC SENTRY ICD/CONCERTO II CRT-D
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS140
Date Received01/13/2009
Decision Date02/10/2009
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modifications to the outlier criteria for the open circuit voltage (ocv) test.
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