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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 NumberS001
Date Received04/06/1998
Decision Date05/21/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an update to the medtronic. Vision software model 9952 - series 2. 0. The update will add the ability to program the medtronic. Kappa 400 models k(dr) 401/403, k(sr) 401/403, the medtronic dx2 models 7970/7972, and will add electrophysiological studies (eps) capability to the kappa 400 pacemakers. The update also incorporates performance enhancements which shorten boot and application load times, provide quicker screen transitions, and reporting and usability enhancements.
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