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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCONCERTO II/MAXIMO II/CONSULTA/CONCERTO CRT-DS/INSYNC MAXIMO/SENTRY/INSYNC II MARQUIS/INSYNC III MARQUIS ICDS
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP010031
Supplement NumberS231
Date Received01/18/2011
Decision Date02/17/2011
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
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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