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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, EVERA S VR, EVERA XT DR
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 NumberS409
Date Received04/08/2013
Decision Date05/03/2013
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
THE IMPLEMENTATION OF FACTORY WORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1; 2) THE APPROVAL OF MANUFACTURING LINES IN A NEW EXTENSION OF A CONTROLLED ENVIRONMENT AREA; 3) NEW PRESSURE TEST EQUIPMENT TO VERIFY HERMETICITY; 4) MODIFICATIONS TO A CONTROLLED ENVIRONMENT; 5) A CHANGE TO THE DESCUM AND CLEANING PROCESS FOR THE 3UM CMOS INTEGRATED CIRCUIT; AND 6) A NEW SOFTWARE VERSION FOR PROCESS DATA COLLECTION SOFTWARE AT A MEDTRONIC SUPPLIER.
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