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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; ATTAIN LEAD; ATTAIN OTW LEAD
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP010015
Supplement NumberS217
Date Received09/06/2013
Decision Date02/27/2014
Product Code NKE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A LABELING UPDATE TO INCLUDE THE RESULTS FROM THE POST-APPROVAL STUDY, SPECIFICALLY THE MEDTRONIC INSYNC REGISTRY POST APPROVAL STUDY
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