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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.
 
DeviceKAPPA 400 DR IPG,KAPPA 400 SR IPG
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMEDTRONIC Inc.
8200 Coral Sea Street NE
Mounds View, MN 55112
PMA NumberP970012
Supplement NumberS096
Date Received12/22/2014
Decision Date10/19/2015
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
Approval OrderApproval Order
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