|Trade Name||ADVISA SR MRI|
|Classification Name||pulse generator, permanent, implantable|
|Generic Name||implantable pulse generator|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Nine (9) manufacturing changes for advisa sr mri that had been previously reviewed and accepted to align the advisa sr mri manufacturing process with the predecessor device manufacturing processes: 1) antenna wire bond coat manufacturing standardization; 2) update to distribution center sorter tool (dcst) system; 3) new supplier for gold preform component (brazing preform for feed-through manufacturing); 4) second source supplier of anode substrates; 5) vapor degreaser cleaning back proliferation to legacy products; 6) new 3d laser marker at mjc; 7) statek crystal with pre-plated ceramic base statek crystal with pre-plated ceramic base; 8) alternative uv irradiation equipment for dieprep area; and 9) modification of m017/m019 probe test software.