PMA - Premarket Approval

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New Search Back to Search Results 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 Name MEDTRONIC 9891 BASELINE SOFTWARE/9891 A EPS Classification Name implantable pacemaker pulse-generator Generic Name pulse generator Regulation Number 870.3610 Applicant MEDTRONIC VASCULAR PMA Number P890003 Supplement Number S044 Date Received 03/14/1996 Decision Date 09/18/1996 Product Code DXY [ Registered Establishments with DXY ] Advisory Committee Cardiovascular Supplement Type normal 180 day track Supplement Reason change design/components/specifications - software Expedited Review Granted? No Approval Order Statement  Approval for the models 9891 and 9891a programmer software (baseline 7) for use with the model 9790 and 9790c programmers.