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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.
 
DeviceINSYNC/INSYNC III CRT-IPGS, MODEL 8040/8042
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP010015
Supplement NumberS019
Date Received12/09/2005
Decision Date05/12/2006
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
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