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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 NameKAPPA 400 DR/SR
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator
Applicant MEDTRONIC INC.
PMA NumberP970012
Supplement NumberS041
Date Received08/11/2008
Decision Date09/10/2008
Product Code
NVZ[ Registered Establishments with NVZ ]
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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