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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 IPG
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator
Applicant MEDTRONIC INC.
PMA NumberP970012
Supplement NumberS088
Date Received07/06/2011
Decision Date08/04/2011
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 
Manufacturing process change for the determination of worst case device representative for ethylene oxide (eo) residual testing for ethylene oxide sterilization.
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