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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/DX2 AND KAPPA 700/600 PACEMAKERS
Generic Nameimplantable pulse generator programming software
ApplicantMEDTRONIC VASCULAR
PMA NumberP980035
Supplement NumberS005
Date Received11/30/1999
Decision Date12/23/1999
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic vision software model 9952/9952a series 3. 0 (to program the medtronic kappa 400/dx2 devices) and the medtronic vision software model 9953/9953a series 3. 0 (to program the medtronic kappa 700/600 devices). The devices are indicated for use with the medtronic model 9790 and model 9790c programmers for the interrogation and programming of implantable pulse generators via radiofrequency telemetry.
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