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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.
 
DeviceACTIVITRAX II IPG,ACTIVITRAX IPG,LEGEND II IPG,LEGEND IPG,MICRO MINIX IPG,MINIX IPG,MINIX ST IPG,PREMIER IPG,PREVAIL IPG
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantMEDTRONIC Inc.
8200 Coral Sea Street NE
Mounds View, MN 55112
PMA NumberP850051
Supplement NumberS082
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
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER.
Approval OrderApproval Order
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