|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|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the design specification and manufacturing process for the beta-rail 3. 5f delivery catheter (with 30 and 40 mm indicator source train).