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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 NameSYNERGYST II MEDTRONIC MODEL 9889E SOFTWARE
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS042
Date Received08/16/1995
Decision Date10/31/1995
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to market software (model 9889e) which is designed to provide programming capabilities, using the already approved 9790 and 9790a programmers for three models of pulse generators as relabeled for distribution by another company, cpi under their trade names. The pacemakers are: the legend to be relabeled as triumph vr, elite to be relabeled as prelude dr and synergyst ii to be relabeled as triumph dr.
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