|Trade Name||MEDTRONIC SIGMA SERIES PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEM|
|Generic Name||implantable pulse generator programming software|
|Supplement Type||real-time process|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the sigma and 350 pacing systems, specifically: modify the bottom of the connector by adding a 0. 020 recess on the underside area between the connector and the can; change interconnect ribbon material; modify connector icr area by adding walls between interconnect ribbons; modify icr weld configuration; change material for set screw blocks; modify 3. 2mm connector bores; increase polyurethane thick ness on outside of connector in ultrasonic weld zones; preformed icrs; minimum adhesive fill line added around the perimeter of the fill area.