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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 NameINSYNC III/II MARQUIS CRT-D/INSYNC SENTRY/MAXIMO CRT-D/CONCERTO/CONSULTA/CONCERTO II/MAXIMO II CRT-D
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS219
Date Received10/26/2010
Decision Date11/23/2010
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of an updated version of the statistical process control (spc) software system across multiple manufacturing locations and vertically integrated suppliers.
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