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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 THERA, PRODIGY AND PREVA PULSE GENERATORS
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP890003
Supplement NumberS043
Date Received02/09/1996
Decision Date07/01/1996
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MARKETING OF A SUBSET OF PULSE GENERATROS FROM THE APPROVED THERA-I/PRODIGY HARDWARE AND SOFTWARE PLATFORMS. THE DEVICES AS MODIFIED, WILL BE MARKETED UNDER THE FOLLOWING TRADE NAMES:MEDTRONIC:THERA MODEL 7968I PULSE GENERATOR; PRODIGY MODEL 8158 PULSE GENERATOR; PREVA MODELS 7088, 7089, 8088, AND 8089 PULSE GENERATORS; MODELS 9898E AND 9899E SOFTWARE - VITATRON:LEGACY II MODELS 126/128/526/528/726/728/826/828 PULSE GENERATORS; VISA MODELS 115/116/415/416/425/426/435/436 PULSE GENERATORS; AND MODEL 9849E SOFTWARE
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