|Trade Name||BETA-CATH(TM) SYSTEM|
|Classification Name||intravascular radiation delivery system|
|Generic Name||intravascular brachytherapy system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| postapproval protocol or modification to a protocol|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the post-approval study protocol for the beta-cath(tm) system. The post-approval study is intended to verify that the corrective actions, intended to help minimize the incidence of device failures and malfunctions seen during the premarket clinical investigation, are successful in reducing the device failure and malfunction rate.