|Trade Name||PALMAZ BALLOON EXPANDABLE STENTS|
|Classification Name||stent, coronary|
|Generic Name||iliac stent|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval is for additional models of the palmaz balloon expandable stent and the use of the opta lp and powerflex plus balloon catheters as delivery systems for the stents. The additional stent models include stents with an expansion range from 6 to 8 mm and lengths from 10 to 30 mm.