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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 FAMILY OF PACEMAKERS
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 NumberS020
Date Received12/09/2005
Decision Date05/12/2006
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic model 2091 wb wireless pc card for use with medtronic model 9986 desktop/boss (sw version 1. 5) for the medtronic carelink programmer (model 2090) for all medtronic and vitatron pacemaker and icd models.
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