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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.
 
DeviceKAPPA 400 DR/SR
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
MEDTRONIC Inc.
8200 coral sea street ne
mounds view, MN 55112
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 - manufacturer/sterilizer/packager/supplier
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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