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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.
 
DeviceSYNERGYST II MEDTRONIC MODEL 9889E SOFTWARE
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS042
Date Received08/16/1995
Decision Date10/31/1995
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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