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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 IPG PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator
Applicant MEDTRONIC INC.
PMA NumberP970012
Supplement NumberS038
Date Received07/28/2008
Decision Date11/21/2008
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for component, design, manufacturing process, and labeling updates to the medtronic 2090 carelink programmer, which are driven by component obsolescence. Updates include a new touch screen, a new liquid crystal display (lcd), a local area network (lan) on the micro-processing unit (mpu), new hard drives, updates to the link electronics module (lem), and other minor changes to address obsolete components.
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