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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.
DeviceKAPPA 400 SR
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
8200 coral sea street ne
mounds view, MN 55112
PMA NumberP970012
Supplement NumberS042
Date Received08/12/2008
Decision Date09/11/2008
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the battery burn-in process.