|Trade Name||BETA-CATH 3.5F SYSTEM - 60 MM|
|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 60 mm beta-cath 3. 5f system. The device, as modified, 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 for the 30 mm and 40 mm systems and injury areas up to 40 mm for the 60 mm system) in a reference vessel diameter ranging from 2. 7 mm to 4. 0 mm.