|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||ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM|
|Classification Name||catheter, coronary, atherectomy|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new device, the angiojet ultra system with the distaflex thrombectomy set with a 3 french distal diameter. The device, as modified, will be marketed under the trade name angiojet ultra system with the distaflex thrombectomy set and is indicated for removing thrombus in the treatment of patients with symptomatic coronary artery or svg lesions in vessels ¿ 2. 0 mm in diameter prior to balloon angioplasty or stent placement.