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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 706 SR IPG
Generic Nameimplantable pulse generator programming software
ApplicantMEDTRONIC VASCULAR
PMA NumberP980035
Supplement NumberS007
Date Received04/10/2000
Decision Date05/11/2000
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to header part number 149422 for use with the kappa sr model 706.
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