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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 NameMEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
Applicant MEDTRONIC INC.
PMA NumberP970012
Supplement NumberS003
Date Received06/12/1998
Decision Date07/14/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Requested a change in the application pattern of the epoxy ara that affixes the device battery tot he insulator cup, and an epoxy bead or fillet will be added between the battery and the hybrid.
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