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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.
 
DeviceEGMP5 DOWNLOAD SOFTWARE APPLICATION,EVERA S DR ICD.EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PATIENT
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 NumberS469
Date Received02/27/2014
Decision Date03/12/2014
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
USE OF FACTORYWORKS RELEASE 7.10 AT SEVERAL OF MEDTRONIC¿S MANUFACTURING FACILITIES.
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