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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/CONCERTO II/CONSULTA/DF4/INSYNC II/III/MAXIMO/SENTRY/MAXIMO II/II M4/PROTECTA XT/PROTECTA/PROTECTA XT M4/M4
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS255
Date Received05/10/2011
Decision Date06/09/2011
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF AN ETHYLENE OXIDE (ETO) STERILIZER SYSTEM.
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