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Device | MEDTRONIC KAPPA 700/600 PACING SYSTEM WITH MODEL 9953-SERIES 1.1 SOFTWARE |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S001 |
Date Received | 03/10/1999 |
Decision Date | 04/01/1999 |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |