|Trade Name||PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM|
|Generic Name||balloon stent|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the indication of treatment of restenotic native coronary artery lesions with arefernce diameter in the range of 3-4 mm, and modifications ot the current albel that include addition ofthe stars trial results to the clinical summary section.