|Trade Name||NOVOSTE 40 MM BETA-CATH SYSTEM|
|Classification Name||intravascular radiation delivery system|
|Generic Name||intravascular brachytherapy system|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the novoste(tm) 40 mm beta-cath system. The novoste(tm) 40 mm beta-cath(tm) system is intended to deliver beta radiation to the site of successful percutaneous coronary intervention (pci) for the treatment of in-stent restenosis in native coronary arteries with discrete lesions (treatable with a 20 mm balloon) in a reference vessel diameter ranging from 2. 7 to 4. 0 mm.