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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 MRI XT DR SURESCAN ICD, EVERA MRI XT VR SURESCAN ICD,EVERA MRI S DR SURESCAN ICD, EVERA MRI S VR SURESCAN ICD
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980016
Supplement NumberS549
Date Received09/15/2015
Decision Date10/14/2015
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MANUFACTURING CHANGES: EXPANSION OF A CONTROLLED ENVIRONMENT AREA, ADDITION OF A LASER WELDING SYSTEM, UPDATE TO HYBRID TRACKING DURING MANUFACTURING, CONNECTOR MOLDING MANUFACTURING PROCESS CHANGE, ADDITION OF A SOAK OVEN TEMPERATURE VERIFICATION, AND IMPLEMENTATION OF A CONTINUOUS MONITORING SYSTEM.
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