|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 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 modifications to the alpha-series transfer devices (alpha iv, rev. 2, alpha v, and alpha vi), and modifications to the labeling for the beta-cath 5f and beta-cath 3. 5f systems.