|Trade Name||NOVOSTE BETA-CATH 3.5 FR SYSTEM|
|Classification Name||intravascular radiation delivery system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the novoste beta-cath 3. 5 fr system. The novoste beta-cath 3. 5 fr system is indicated 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 mm to 4. 0 mm.