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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 SERIES OF PACEMAKERS
Generic Nameimplantable pulse generator programming software
ApplicantMEDTRONIC VASCULAR
PMA NumberP980035
Supplement NumberS006
Date Received12/06/1999
Decision Date12/20/1999
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a correction to the shipping box label for the model kdr 721 pacemaker properly identifying the contents as a "dual chamber rate responsive pacemaker. ".
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