|Trade Name||MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS|
|Classification Name||stent, coronary|
|Applicant||ARTERIAL VASCULAR ENGINEERING, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Requested a change to utilize a circular "ring" light source to apply the uv light during the uv adhesive curing process. The requested change will provide constant 360 degree application of uv light to the uv adhesive and will no longer require rotation of the catheter assembly. This process change will eliminate the need for nitrogen cooling gas and will reduce the process time for the distal luer bond from 60 seconds to 38 seconds.