|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 |
Fourteen (14) 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) tooling changes and alternate supplier for ft insulator; 2) manufacturing process change for printed wiring board substrates; 3) leak check tester with software updates; 4) new material supplier and specification update for p(etfe); 5) plasma cleaning process change; 6) factoryworks release 7. 11; and 7) space data collector tracking system update at nikon rout; 8) update to final assembly processing temperature requirements 9) universal burn in test system (ubits) software update; 10) modify in-process battery inspection requirements; 11) vision system implementation at mjc sterilization area; 12) vision system for connector and radiopaque verification at smo; 13) ic die sorter equipment software configuration update; and 14) final visual criteria change.