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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.
 
DeviceEVERA S DR ICD,EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD, VIVA/BRAVA/EVERA PROGRAMMER APPLICATION SOFTWARE
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MS MVS11
MOUNDS VIEW, MN 55112
PMA NumberP980016
Supplement NumberS451
Date Received12/16/2013
Decision Date02/27/2014
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR POST STERILIZATION TEST FIRMWARE, PROGRAMMER APPLICATION SOFTWARE AND LABELING FOR THE DEVICES.
Approval OrderApproval Order
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