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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 700/600/800/900 PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pulse generator programming software
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP980035
Supplement NumberS023
Date Received03/12/2002
Decision Date03/15/2002
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two changes in the manufacturing process involving the epoxy dispense program and the wire bond loop program.
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