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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 CRT-D/CONCERTO/CONSULTA/MAXIMO II & VARIOUS INSYNC FAMILIES OF ICDS
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS117
Date Received08/11/2008
Decision Date09/10/2008
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition fo an eto sterilizer at the tolochenaz, switzerland facility and changes to the ethylene oxide sterilization lethality model. The addition of the eto sterilizer is not applicable to the following devices: consulta, maximo ii, secura dr/vr family, and maximo ii ddr/vr family.
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