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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.
 
DeviceCONSULTA, INSYNC, INSYNC III, SYNCRA
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP010015
Supplement NumberS160
Date Received04/04/2012
Decision Date04/25/2012
Product Code OJX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR SOFTWARE UPDATES AND MINOR SOFTWARE ENHANCEMENTS TOMEDTRONIC MODEL 9986 DESKTOP/ BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSION 2.6 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
Post-Approval StudyShow Report Schedule and Study Progress
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