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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC KAPPA 700/600 PACING SYSTEM WITH MODEL 9953-SERIES 1.1 SOFTWARE
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP980035
Supplement NumberS001
Date Received03/10/1999
Decision Date04/01/1999
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Medtronic.Vision Software Models 9953 and 9953A (Series 1.3) for use with the Medtronic Model 9790 programmers to program the Medtronic Kappa 700 series pacemakers. The device, as modified, will be marketed under the trade name Medtronic.Vision Software Models 9953/9953A and is indicated for use with the Medtronic Kappa 700 series pacemakers to allow electrophysiology stimulation (EPS) functions.
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