|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 RHEDOLYTIC THROMBECTOMY SYSTEM CORONARY USE|
|Classification Name||catheter, coronary, atherectomy|
|Applicant||POSSIS MEDICAL, INC.|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of a boxed warning regarding use in pulmonary vasculature to all possis angiojet catheter instruction for use documents.