|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||NOVOSTE BETA-CATH 3.5F SYSTEM|
|Classification Name||intravascular radiation delivery system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the beta-rail 3. 5f delivery catheter with distal improvements, and a change in the procedure accessory pack.