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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.
 
DeviceAzure XT DR/SR Mri SureScan IPG; Azure S DR/SR MRI Sure Scan IPG
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980035
Supplement NumberS520
Date Received09/19/2017
Decision Date10/05/2017
Product Code NVZ 
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  
Update to the manufacturing execution system to FACTORYworks 9.1, an additional vision system for inspection of final packaged devices, and changes to heavy metal testing for silicone.
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