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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 PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator
Applicant MEDTRONIC INC.
PMA NumberP970012
Supplement NumberS039
Date Received08/04/2008
Decision Date04/21/2009
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the addition of an ethylene oxide sterilizer.
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