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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 600/700/800/900 & ENPULSE FAMILIES OF PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator programming software
ApplicantMEDTRONIC VASCULAR
PMA NumberP980035
Supplement NumberS061
Date Received08/21/2006
Decision Date09/19/2006
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at trivirix minneapolis, inc. , milaca, minnesota for the final testing, activating, labeling and packaging of the model 2490h carelink monitor and the model 2020a cardiosight reader.
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