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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.
 
DeviceELITE,ELITE II,MINUET,PREVA,PRODIGY,THERA D,THERA DR IPGS, THERA ID PG,THERA IPG,THERA S IPG,THERA SR IPG,THERA VDD IPG,
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP890003
Supplement NumberS326
Date Received12/22/2014
Decision Date10/19/2015
Product Code NVZ 
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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